Trial Outcomes & Findings for Trial To Evaluate The Safety, Tolerability, And Immunogenicity Of A Multivalent Group B Streptococcus Vaccine In Healthy Nonpregnant Women And Pregnant Women And Their Infants (NCT NCT03765073)

Last Updated: 2025-08-05

Results Overview

Local reactions (redness, swelling, and pain at the injection site of the left arm) were recorded by participants in e-diary. Erythema/Redness and induration/swelling were measured and recorded in measuring device units (1 measuring device unit=0.5 centimeter \[cm\]). Grading: Grade 1/mild (greater than \[\>\] 2.5 to 5.0 cm), Grade 2/moderate (\>5.0 to 10.0 cm), Grade 3/severe (\>10.0 cm) and Grade 4 (necrosis \[swelling\] or necrosis or exfoliative dermatitis \[redness\]). Pain at injection site was graded as Grade 1/mild (did not interfere with activity), Grade2/moderate (interfered with activity), Grade 3/severe (prevented daily activity) and Grade 4 (emergency room \[ER\] visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

1208 participants

Primary outcome timeframe

Day 1 (day of vaccination) to Day 7 after Primary Dose

Results posted on

2025-08-05

Participant Flow

Healthy non-pregnant participants, pregnant maternal participants between 18 to 40 years of age and infants who were born to these maternal participants were enrolled in this study. This study conducted in three stages and participants were enrolled to Stage 1, 2 and 3 separately.

A total of 66 nonpregnant women and 576 maternal participants and their 566 infants were enrolled in this study. Infants were not randomized and vaccinated in this study but summarized according to the vaccine group their mothers were randomized to. Vaccination was administered preferably to the nondominant arm of the participants.

Participant milestones

Participant milestones
Measure	Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) Nonpregnant participants were randomized to receive a single dose of 20 microgram of Group B Streptococcus 6-valent (GBS6) vaccine with aluminium phosphate, intramuscularly, preferably in nondominant arm on Day 1.	Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) Nonpregnant participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly, preferably in nondominant arm on Day 1.	Stage 1: Placebo (Nonpregnant) Non pregnant participants were randomized to receive placebo (saline control) intramuscularly, preferably in nondominant arm on Day 1.	Stage 2: GBS6 5 mcg With AlPO4 (Maternal) Maternal participants were randomized to receive a single dose of 5 μg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 5 mcg Without AlPO4 (Maternal) Maternal participants were randomized to receive a single dose of 5 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 10 mcg With AlPO4 (Maternal) Maternal participants were randomized to receive a single dose of 10 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) Maternal participants were randomized to receive a single dose of 10 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg With AlPO4 (Maternal) Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: Placebo (Maternal) Maternal participants were randomized to receive placebo (saline control) intramuscularly on Day 1.	Stage 2: GBS6 5 mcg With AlPO4 (Infant) Infant participants born to the maternal participants randomized to receive a single dose of 5 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 5 mcg Without AlPO4 (Infant) Infant participants born to the maternal participants randomized to receive a single dose of 5 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 10 mcg With AlPO4 (Infant) Infant participants born to the maternal participants randomized to receive a single dose of 10 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 10 mcg Without AlPO4 (Infant) Infant participants born to the maternal participants randomized to receive a single dose of 10 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg With AlPO4 (Infant) Infant participants born to the maternal participants randomized to receive a single dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg Without AlPO4 (Infant) Infant participants born to the maternal participants randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: Placebo (Infant) Infant participants born to the maternal participants randomized to receive placebo (saline control) intramuscularly on Day 1.	Stage 3: GBS6 20 mcg Without AlPO4 (Maternal) Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AIPO4, intramuscularly on Day 1.	Stage 3: Placebo (Maternal) Maternal participants were randomized to receive placebo (saline control) intramuscularly on Day 1.	Stage 3: GBS6 20 mcg Without AlPO4 (Infant) Infant participants born to the maternal participants randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 3: Placebo (Infant) Infant participants were randomized to receive placebo (saline control) intramuscularly on Day 1.
Stage 1 STARTED	22	22	22	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Stage 1 Booster Vaccination	11	7	8	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Stage 1 COMPLETED	21	21	22	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Stage 1 NOT COMPLETED	1	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Stage 2 STARTED	0	0	0	40	40	40	40	40	40	120	40	39	40	40	40	40	118	0	0	0	0
Stage 2 COMPLETED	0	0	0	32	36	37	37	35	38	105	32	34	36	36	36	38	105	0	0	0	0
Stage 2 NOT COMPLETED	0	0	0	8	4	3	3	5	2	15	8	5	4	4	4	2	13	0	0	0	0
Stage 3 STARTED	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	108	108	104	105
Stage 3 COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	91	88	86	87
Stage 3 NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	17	20	18	18

Reasons for withdrawal

Reasons for withdrawal
Measure	Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) Nonpregnant participants were randomized to receive a single dose of 20 microgram of Group B Streptococcus 6-valent (GBS6) vaccine with aluminium phosphate, intramuscularly, preferably in nondominant arm on Day 1.	Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) Nonpregnant participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly, preferably in nondominant arm on Day 1.	Stage 2: GBS6 5 mcg With AlPO4 (Maternal) Maternal participants were randomized to receive a single dose of 5 μg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 5 mcg Without AlPO4 (Maternal) Maternal participants were randomized to receive a single dose of 5 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 10 mcg With AlPO4 (Maternal) Maternal participants were randomized to receive a single dose of 10 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) Maternal participants were randomized to receive a single dose of 10 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg With AlPO4 (Maternal) Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: Placebo (Maternal) Maternal participants were randomized to receive placebo (saline control) intramuscularly on Day 1.	Stage 2: GBS6 5 mcg With AlPO4 (Infant) Infant participants born to the maternal participants randomized to receive a single dose of 5 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 5 mcg Without AlPO4 (Infant) Infant participants born to the maternal participants randomized to receive a single dose of 5 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 10 mcg With AlPO4 (Infant) Infant participants born to the maternal participants randomized to receive a single dose of 10 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 10 mcg Without AlPO4 (Infant) Infant participants born to the maternal participants randomized to receive a single dose of 10 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg With AlPO4 (Infant) Infant participants born to the maternal participants randomized to receive a single dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg Without AlPO4 (Infant) Infant participants born to the maternal participants randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: Placebo (Infant) Infant participants born to the maternal participants randomized to receive placebo (saline control) intramuscularly on Day 1.	Stage 3: GBS6 20 mcg Without AlPO4 (Maternal) Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AIPO4, intramuscularly on Day 1.	Stage 3: Placebo (Maternal) Maternal participants were randomized to receive placebo (saline control) intramuscularly on Day 1.	Stage 3: GBS6 20 mcg Without AlPO4 (Infant) Infant participants born to the maternal participants randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 3: Placebo (Infant) Infant participants were randomized to receive placebo (saline control) intramuscularly on Day 1.
Stage 1 Lost to Follow-up	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Stage 1 Withdrawal by participant	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Stage 2 Death	0	0	0	0	0	0	0	0	1	0	1	0	0	0	0	2	0	0	0	0
Stage 2 Lost to Follow-up	0	0	5	1	0	3	3	1	6	5	1	1	3	3	1	6	0	0	0	0
Stage 2 Other	0	0	0	0	0	0	1	1	3	0	0	0	0	0	1	2	0	0	0	0
Stage 2 Withdrawal by parent/guardian	0	0	0	0	0	0	0	0	0	3	3	3	1	1	0	3	0	0	0	0
Stage 2 Withdrawal by Subject	0	0	3	3	3	0	1	0	5	0	0	0	0	0	0	0	0	0	0	0
Stage 3 Adverse Event	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0
Stage 3 Death	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	3	2
Stage 3 Lost to Follow-up	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	8	5	7	4
Stage 3 No longer meets eligibility criteria	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	1
Stage 3 Other	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	2	2	2
Stage 3 Withdrawal by parent/guardian	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	6	9
Stage 3 Withdrawal by Subject	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	8	11	0	0

Baseline Characteristics

Trial To Evaluate The Safety, Tolerability, And Immunogenicity Of A Multivalent Group B Streptococcus Vaccine In Healthy Nonpregnant Women And Pregnant Women And Their Infants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) n=22 Participants Nonpregnant participants were randomized to receive a single dose of 20 microgram of Group B Streptococcus 6-valent (GBS6) vaccine with aluminium phosphate, intramuscularly on Day 1.	Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) n=22 Participants Nonpregnant participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 1: Placebo (Nonpregnant) n=22 Participants Non pregnant participants were randomized to receive placebo (saline control) intramuscularly on Day 1.	Stage 2: GBS6 5 mcg With AlPO4 (Maternal) n=40 Participants Maternal participants were randomized to receive a single dose of 5 μg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 5 mcg Without AlPO4 (Maternal) n=40 Participants Maternal participants were randomized to receive a single dose of 5 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 10 mcg With AlPO4 (Maternal) n=40 Participants Maternal participants were randomized to receive a single dose of 10 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) n=40 Participants Maternal participants were randomized to receive a single dose of 10 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg With AlPO4 (Maternal) n=40 Participants Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) n=40 Participants Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: Placebo (Maternal) n=120 Participants Maternal participants were randomized to receive placebo (saline control) intramuscularly on Day 1.	Stage 2: GBS6 5 mcg With AlPO4 (Infant) n=40 Participants Infant participants born to the maternal participants randomized to receive a single dose of 5 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 5 mcg Without AlPO4 (Infant) n=39 Participants Infant participants born to the maternal participants randomized to receive a single dose of 5 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 10 mcg With AlPO4 (Infant) n=40 Participants Infant participants born to the maternal participants randomized to receive a single dose of 10 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 10 mcg Without AlPO4 (Infant) n=40 Participants Infant participants born to the maternal participants randomized to receive a single dose of 10 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg With AlPO4 (Infant) n=40 Participants Infant participants born to the maternal participants randomized to receive a single dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg Without AlPO4 (Infant) n=40 Participants Infant participants born to the maternal participants randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: Placebo (Infant) n=118 Participants Infant participants born to the maternal participants randomized to receive placebo (saline control) intramuscularly on Day 1.	Stage 3: GBS6 20 mcg Without AlPO4 (Maternal) n=108 Participants Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AIPO4, intramuscularly on Day 1.	Stage 3: Placebo (Maternal) n=108 Participants Maternal participants were randomized to receive placebo (saline control) intramuscularly on Day 1.	Stage 3: GBS6 20 mcg Without AlPO4 (Infant) n=104 Participants Infant participants born to the maternal participants randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 3: Placebo (Infant) n=105 Participants Infant participants were randomized to receive placebo (saline control) intramuscularly on Day 1.	Total n=1208 Participants Total of all reporting groups
Age, Customized Full term newborn infants (Gestational age >= 37 weeks)	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	37 Participants n=42 Participants	36 Participants n=42 Participants	39 Participants n=36 Participants	40 Participants n=36 Participants	39 Participants n=24 Participants	39 Participants n=135 Participants	116 Participants n=136 Participants	0 Participants n=44 Participants	0 Participants n=667 Participants	95 Participants n=7 Participants	98 Participants n=6 Participants	539 Participants n=10 Participants
Age, Customized Preterm newborn infants (Gestational age <37 weeks)	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	3 Participants n=42 Participants	3 Participants n=42 Participants	1 Participants n=36 Participants	0 Participants n=36 Participants	1 Participants n=24 Participants	1 Participants n=135 Participants	2 Participants n=136 Participants	0 Participants n=44 Participants	0 Participants n=667 Participants	8 Participants n=7 Participants	6 Participants n=6 Participants	25 Participants n=10 Participants
Age, Customized Unknown	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	0 Participants n=24 Participants	0 Participants n=135 Participants	0 Participants n=136 Participants	0 Participants n=44 Participants	0 Participants n=667 Participants	1 Participants n=7 Participants	1 Participants n=6 Participants	2 Participants n=10 Participants
Age, Customized 18-40 Years	22 Participants n=5 Participants	22 Participants n=7 Participants	22 Participants n=5 Participants	40 Participants n=4 Participants	40 Participants n=21 Participants	40 Participants n=10 Participants	40 Participants n=115 Participants	40 Participants n=24 Participants	40 Participants n=42 Participants	120 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	0 Participants n=24 Participants	0 Participants n=135 Participants	0 Participants n=136 Participants	108 Participants n=44 Participants	108 Participants n=667 Participants	0 Participants n=7 Participants	0 Participants n=6 Participants	642 Participants n=10 Participants
Sex: Female, Male Female	22 Participants n=5 Participants	22 Participants n=7 Participants	22 Participants n=5 Participants	40 Participants n=4 Participants	40 Participants n=21 Participants	40 Participants n=10 Participants	40 Participants n=115 Participants	40 Participants n=24 Participants	40 Participants n=42 Participants	120 Participants n=42 Participants	17 Participants n=42 Participants	20 Participants n=42 Participants	19 Participants n=36 Participants	20 Participants n=36 Participants	26 Participants n=24 Participants	21 Participants n=135 Participants	55 Participants n=136 Participants	108 Participants n=44 Participants	108 Participants n=667 Participants	60 Participants n=7 Participants	54 Participants n=6 Participants	934 Participants n=10 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	23 Participants n=42 Participants	19 Participants n=42 Participants	21 Participants n=36 Participants	20 Participants n=36 Participants	14 Participants n=24 Participants	19 Participants n=135 Participants	63 Participants n=136 Participants	0 Participants n=44 Participants	0 Participants n=667 Participants	44 Participants n=7 Participants	51 Participants n=6 Participants	274 Participants n=10 Participants
Race/Ethnicity, Customized Race · Black or African American	22 Participants n=5 Participants	22 Participants n=7 Participants	22 Participants n=5 Participants	40 Participants n=4 Participants	40 Participants n=21 Participants	40 Participants n=10 Participants	40 Participants n=115 Participants	40 Participants n=24 Participants	40 Participants n=42 Participants	120 Participants n=42 Participants	40 Participants n=42 Participants	39 Participants n=42 Participants	40 Participants n=36 Participants	40 Participants n=36 Participants	40 Participants n=24 Participants	40 Participants n=135 Participants	118 Participants n=136 Participants	82 Participants n=44 Participants	80 Participants n=667 Participants	78 Participants n=7 Participants	78 Participants n=6 Participants	1101 Participants n=10 Participants
Race/Ethnicity, Customized Race · Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	0 Participants n=24 Participants	0 Participants n=135 Participants	0 Participants n=136 Participants	1 Participants n=44 Participants	1 Participants n=667 Participants	1 Participants n=7 Participants	1 Participants n=6 Participants	4 Participants n=10 Participants
Race/Ethnicity, Customized Race · White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	0 Participants n=24 Participants	0 Participants n=135 Participants	0 Participants n=136 Participants	23 Participants n=44 Participants	24 Participants n=667 Participants	23 Participants n=7 Participants	22 Participants n=6 Participants	92 Participants n=10 Participants
Race/Ethnicity, Customized Race · Multiracial	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	0 Participants n=24 Participants	0 Participants n=135 Participants	0 Participants n=136 Participants	0 Participants n=44 Participants	3 Participants n=667 Participants	0 Participants n=7 Participants	3 Participants n=6 Participants	6 Participants n=10 Participants
Race/Ethnicity, Customized Race · Not reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	0 Participants n=24 Participants	0 Participants n=135 Participants	0 Participants n=136 Participants	2 Participants n=44 Participants	0 Participants n=667 Participants	2 Participants n=7 Participants	1 Participants n=6 Participants	5 Participants n=10 Participants
Race/Ethnicity, Customized Ethnicity · Non-Hispanic/non-Latino	22 Participants n=5 Participants	22 Participants n=7 Participants	22 Participants n=5 Participants	40 Participants n=4 Participants	40 Participants n=21 Participants	40 Participants n=10 Participants	40 Participants n=115 Participants	40 Participants n=24 Participants	40 Participants n=42 Participants	120 Participants n=42 Participants	40 Participants n=42 Participants	39 Participants n=42 Participants	40 Participants n=36 Participants	40 Participants n=36 Participants	40 Participants n=24 Participants	40 Participants n=135 Participants	118 Participants n=136 Participants	100 Participants n=44 Participants	102 Participants n=667 Participants	96 Participants n=7 Participants	99 Participants n=6 Participants	1180 Participants n=10 Participants
Race/Ethnicity, Customized Ethnicity · Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	0 Participants n=24 Participants	0 Participants n=135 Participants	0 Participants n=136 Participants	8 Participants n=44 Participants	6 Participants n=667 Participants	8 Participants n=7 Participants	6 Participants n=6 Participants	28 Participants n=10 Participants

PRIMARY outcome

Timeframe: Day 1 (day of vaccination) to Day 7 after Primary Dose

Population: Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.

Outcome measures

Outcome measures
Measure	Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) n=22 Participants Nonpregnant participants were randomized to receive a primary of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) n=22 Participants Nonpregnant participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 1: Placebo (Nonpregnant) n=22 Participants Non pregnant participants were randomized to receive placebo (saline control) intramuscularly on Day 1.	Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) Maternal participants were randomized to receive a single dose of 10 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg With AlPO4 (Maternal) Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: Placebo (Maternal) Maternal participants were randomized to receive placebo (saline control) intramuscularly on Day 1.
Percentage of Participants Reporting Local Reactions Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 Pain at injection site (Any)	27.3 Percentage of Participants Interval 10.7 to 50.2	27.3 Percentage of Participants Interval 10.7 to 50.2	13.6 Percentage of Participants Interval 2.9 to 34.9	—	—	—	—
Percentage of Participants Reporting Local Reactions Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 Pain at injection site (Mild)	22.7 Percentage of Participants Interval 7.8 to 45.4	13.6 Percentage of Participants Interval 2.9 to 34.9	9.1 Percentage of Participants Interval 1.1 to 29.2	—	—	—	—
Percentage of Participants Reporting Local Reactions Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 Pain at injection site (Moderate)	4.5 Percentage of Participants Interval 0.1 to 22.8	13.6 Percentage of Participants Interval 2.9 to 34.9	4.5 Percentage of Participants Interval 0.1 to 22.8	—	—	—	—
Percentage of Participants Reporting Local Reactions Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 Pain at injection site (Severe)	0 Percentage of Participants Interval 0.0 to 15.4	0 Percentage of Participants Interval 0.0 to 15.4	0 Percentage of Participants Interval 0.0 to 15.4	—	—	—	—
Percentage of Participants Reporting Local Reactions Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 Pain at injection site (Grade 4)	0 Percentage of Participants Interval 0.0 to 15.4	0 Percentage of Participants Interval 0.0 to 15.4	0 Percentage of Participants Interval 0.0 to 15.4	—	—	—	—
Percentage of Participants Reporting Local Reactions Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 Erythema/redness (Any)	4.5 Percentage of Participants Interval 0.1 to 22.8	4.5 Percentage of Participants Interval 0.1 to 22.8	4.5 Percentage of Participants Interval 0.1 to 22.8	—	—	—	—
Percentage of Participants Reporting Local Reactions Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 Erythema/redness (Mild)	4.5 Percentage of Participants Interval 0.1 to 22.8	0 Percentage of Participants Interval 0.0 to 15.4	4.5 Percentage of Participants Interval 0.1 to 22.8	—	—	—	—
Percentage of Participants Reporting Local Reactions Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 Erythema/redness (Moderate)	0 Percentage of Participants Interval 0.0 to 15.4	4.5 Percentage of Participants Interval 0.1 to 22.8	0 Percentage of Participants Interval 0.0 to 15.4	—	—	—	—
Percentage of Participants Reporting Local Reactions Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 Erythema/redness (Severe)	0 Percentage of Participants Interval 0.0 to 15.4	0 Percentage of Participants Interval 0.0 to 15.4	0 Percentage of Participants Interval 0.0 to 15.4	—	—	—	—
Percentage of Participants Reporting Local Reactions Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 Erythema/redness (Grade 4)	0 Percentage of Participants Interval 0.0 to 15.4	0 Percentage of Participants Interval 0.0 to 15.4	0 Percentage of Participants Interval 0.0 to 15.4	—	—	—	—
Percentage of Participants Reporting Local Reactions Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 Induration/swelling (Any)	9.1 Percentage of Participants Interval 1.1 to 29.2	9.1 Percentage of Participants Interval 1.1 to 29.2	0 Percentage of Participants Interval 0.0 to 15.4	—	—	—	—
Percentage of Participants Reporting Local Reactions Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 Induration/swelling (Mild)	9.1 Percentage of Participants Interval 1.1 to 29.2	4.5 Percentage of Participants Interval 0.1 to 22.8	0 Percentage of Participants Interval 0.0 to 15.4	—	—	—	—
Percentage of Participants Reporting Local Reactions Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 Induration/swelling (Moderate)	0 Percentage of Participants Interval 0.0 to 15.4	4.5 Percentage of Participants Interval 0.1 to 22.8	0 Percentage of Participants Interval 0.0 to 15.4	—	—	—	—
Percentage of Participants Reporting Local Reactions Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 Induration/swelling (Severe)	0 Percentage of Participants Interval 0.0 to 15.4	0 Percentage of Participants Interval 0.0 to 15.4	0 Percentage of Participants Interval 0.0 to 15.4	—	—	—	—
Percentage of Participants Reporting Local Reactions Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 Induration/swelling (Grade 4)	0 Percentage of Participants Interval 0.0 to 15.4	0 Percentage of Participants Interval 0.0 to 15.4	0 Percentage of Participants Interval 0.0 to 15.4	—	—	—	—

PRIMARY outcome

Timeframe: Day 1 (day of vaccination) to Day 7 after booster dose

Population: Safety analysis set included all participants who received a booster dose of GBS6 vaccine or placebo.

Outcome measures

Outcome measures
Measure	Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) n=11 Participants Nonpregnant participants were randomized to receive a primary of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) n=7 Participants Nonpregnant participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 1: Placebo (Nonpregnant) n=8 Participants Non pregnant participants were randomized to receive placebo (saline control) intramuscularly on Day 1.	Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) Maternal participants were randomized to receive a single dose of 10 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg With AlPO4 (Maternal) Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: Placebo (Maternal) Maternal participants were randomized to receive placebo (saline control) intramuscularly on Day 1.
Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Dose: Non-Pregnant Women Stage 1 Pain at injection site (Any)	72.7 Percentage of Participants Interval 39.0 to 94.0	28.6 Percentage of Participants Interval 3.7 to 71.0	50.0 Percentage of Participants Interval 15.7 to 84.3	—	—	—	—
Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Dose: Non-Pregnant Women Stage 1 Pain at injection site (Mild)	45.5 Percentage of Participants Interval 16.7 to 76.6	28.6 Percentage of Participants Interval 3.7 to 71.0	37.5 Percentage of Participants Interval 8.5 to 75.5	—	—	—	—
Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Dose: Non-Pregnant Women Stage 1 Pain at injection site (Moderate)	27.3 Percentage of Participants Interval 6.0 to 61.0	0 Percentage of Participants Interval 0.0 to 41.0	12.5 Percentage of Participants Interval 0.3 to 52.7	—	—	—	—
Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Dose: Non-Pregnant Women Stage 1 Pain at injection site (Severe)	0 Percentage of Participants Interval 0.0 to 28.5	0 Percentage of Participants Interval 0.0 to 41.0	0 Percentage of Participants Interval 0.0 to 36.9	—	—	—	—
Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Dose: Non-Pregnant Women Stage 1 Pain at injection site (Grade 4)	0 Percentage of Participants Interval 0.0 to 28.5	0 Percentage of Participants Interval 0.0 to 41.0	0 Percentage of Participants Interval 0.0 to 36.9	—	—	—	—
Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Dose: Non-Pregnant Women Stage 1 Erythema/redness (Any)	9.1 Percentage of Participants Interval 0.2 to 41.3	0 Percentage of Participants Interval 0.0 to 41.0	0 Percentage of Participants Interval 0.0 to 36.9	—	—	—	—
Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Dose: Non-Pregnant Women Stage 1 Erythema/redness (Mild)	9.1 Percentage of Participants Interval 0.2 to 41.3	0 Percentage of Participants Interval 0.0 to 41.0	0 Percentage of Participants Interval 0.0 to 36.9	—	—	—	—
Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Dose: Non-Pregnant Women Stage 1 Erythema/redness (Moderate)	0 Percentage of Participants Interval 0.0 to 28.5	0 Percentage of Participants Interval 0.0 to 41.0	0 Percentage of Participants Interval 0.0 to 36.9	—	—	—	—
Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Dose: Non-Pregnant Women Stage 1 Erythema/redness (Severe)	0 Percentage of Participants Interval 0.0 to 28.5	0 Percentage of Participants Interval 0.0 to 41.0	0 Percentage of Participants Interval 0.0 to 36.9	—	—	—	—
Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Dose: Non-Pregnant Women Stage 1 Erythema/redness (Grade 4)	0 Percentage of Participants Interval 0.0 to 28.5	0 Percentage of Participants Interval 0.0 to 41.0	0 Percentage of Participants Interval 0.0 to 36.9	—	—	—	—
Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Dose: Non-Pregnant Women Stage 1 Induration/swelling (Any)	9.1 Percentage of Participants Interval 0.2 to 41.3	0 Percentage of Participants Interval 0.0 to 41.0	0 Percentage of Participants Interval 0.0 to 36.9	—	—	—	—
Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Dose: Non-Pregnant Women Stage 1 Induration/swelling (Mild)	0 Percentage of Participants Interval 0.0 to 28.5	0 Percentage of Participants Interval 0.0 to 41.0	0 Percentage of Participants Interval 0.0 to 36.9	—	—	—	—
Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Dose: Non-Pregnant Women Stage 1 Induration/swelling (Moderate)	9.1 Percentage of Participants Interval 0.2 to 41.3	0 Percentage of Participants Interval 0.0 to 41.0	0 Percentage of Participants Interval 0.0 to 36.9	—	—	—	—
Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Dose: Non-Pregnant Women Stage 1 Induration/swelling (Severe)	0 Percentage of Participants Interval 0.0 to 28.5	0 Percentage of Participants Interval 0.0 to 41.0	0 Percentage of Participants Interval 0.0 to 36.9	—	—	—	—
Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Dose: Non-Pregnant Women Stage 1 Induration/swelling (Grade 4)	0 Percentage of Participants Interval 0.0 to 28.5	0 Percentage of Participants Interval 0.0 to 41.0	0 Percentage of Participants Interval 0.0 to 36.9	—	—	—	—

PRIMARY outcome

Timeframe: Day 1 (day of vaccination) to Day 7 after primary dose

Population: Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.

Systemic events were recorded in e-diary. Fever: oral temperature greater than or equal to (\>=) 38.0 degree Celsius (deg C) and categorized as \>=38.0-38.4 deg C, \>38.4-38.9 deg C, \>38.9-40.0 deg C and \>40.0 deg C. Nausea/vomiting was graded as: Grade 1/mild (1-2 times in 24 hours \[h\]), Grade 2/moderate: (\>2 times in 24h), Grade 3/severe (required intravenous hydration) and Grade 4 (ER visit/hospitalization for hypotensive shock). Diarrhea was graded as: Grade 1/mild (2-3 loose stools in 24h), Grade 2/moderate (4-5 loose stools in 24h), Grade 3/severe (6 or more loose stools in 24h) and Grade 4 (ER visit/hospitalization for severe diarrhea). Fatigue/tiredness, headache, muscle pain and joint pain were graded as: Grade 1/mild (did not interfere with activity), Grade 2/moderate (some interference with activity), Grade 3/severe (prevented daily routine activity) and Grade 4 (ER visit/hospitalization). Grade 4 were classified by investigator or medically qualified person.

Outcome measures

Outcome measures
Measure	Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) n=22 Participants Nonpregnant participants were randomized to receive a primary of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) n=22 Participants Nonpregnant participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 1: Placebo (Nonpregnant) n=22 Participants Non pregnant participants were randomized to receive placebo (saline control) intramuscularly on Day 1.	Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) Maternal participants were randomized to receive a single dose of 10 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg With AlPO4 (Maternal) Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: Placebo (Maternal) Maternal participants were randomized to receive placebo (saline control) intramuscularly on Day 1.
Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 Fever (>=38.0 deg C)	0 Percentage of Participants Interval 0.0 to 15.4	4.5 Percentage of Participants Interval 0.1 to 22.8	0 Percentage of Participants Interval 0.0 to 15.4	—	—	—	—
Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 Fever (38.0 to 38.4 deg C)	0 Percentage of Participants Interval 0.0 to 15.4	0 Percentage of Participants Interval 0.0 to 15.4	0 Percentage of Participants Interval 0.0 to 15.4	—	—	—	—
Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 Fever (38.5 to 38.9 deg C)	0 Percentage of Participants Interval 0.0 to 15.4	4.5 Percentage of Participants Interval 0.1 to 22.8	0 Percentage of Participants Interval 0.0 to 15.4	—	—	—	—
Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 Fever (39.0 to 40.0 deg C)	0 Percentage of Participants Interval 0.0 to 15.4	0 Percentage of Participants Interval 0.0 to 15.4	0 Percentage of Participants Interval 0.0 to 15.4	—	—	—	—
Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 Fever (>40.0 deg C)	0 Percentage of Participants Interval 0.0 to 15.4	0 Percentage of Participants Interval 0.0 to 15.4	0 Percentage of Participants Interval 0.0 to 15.4	—	—	—	—
Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 Nausea/vomiting (Any)	4.5 Percentage of Participants Interval 0.1 to 22.8	9.1 Percentage of Participants Interval 1.1 to 29.2	27.3 Percentage of Participants Interval 10.7 to 50.2	—	—	—	—
Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 Nausea/vomiting (Mild)	0 Percentage of Participants Interval 0.0 to 15.4	4.5 Percentage of Participants Interval 0.1 to 22.8	9.1 Percentage of Participants Interval 1.1 to 29.2	—	—	—	—
Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 Nausea/vomiting (Moderate)	4.5 Percentage of Participants Interval 0.1 to 22.8	4.5 Percentage of Participants Interval 0.1 to 22.8	18.2 Percentage of Participants Interval 5.2 to 40.3	—	—	—	—
Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 Nausea/vomiting (Severe)	0 Percentage of Participants Interval 0.0 to 15.4	0 Percentage of Participants Interval 0.0 to 15.4	0 Percentage of Participants Interval 0.0 to 15.4	—	—	—	—
Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 Nausea/vomiting (Grade 4)	0 Percentage of Participants Interval 0.0 to 15.4	0 Percentage of Participants Interval 0.0 to 15.4	0 Percentage of Participants Interval 0.0 to 15.4	—	—	—	—
Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 Diarrhea (Any)	9.1 Percentage of Participants Interval 1.1 to 29.2	9.1 Percentage of Participants Interval 1.1 to 29.2	18.2 Percentage of Participants Interval 5.2 to 40.3	—	—	—	—
Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 Diarrhea (Mild)	9.1 Percentage of Participants Interval 1.1 to 29.2	9.1 Percentage of Participants Interval 1.1 to 29.2	13.6 Percentage of Participants Interval 2.9 to 34.9	—	—	—	—
Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 Diarrhea (Moderate)	0 Percentage of Participants Interval 0.0 to 15.4	0 Percentage of Participants Interval 0.0 to 15.4	4.5 Percentage of Participants Interval 0.1 to 22.8	—	—	—	—
Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 Diarrhea (Severe)	0 Percentage of Participants Interval 0.0 to 15.4	0 Percentage of Participants Interval 0.0 to 15.4	0 Percentage of Participants Interval 0.0 to 15.4	—	—	—	—
Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 Diarrhea (Grade 4)	0 Percentage of Participants Interval 0.0 to 15.4	0 Percentage of Participants Interval 0.0 to 15.4	0 Percentage of Participants Interval 0.0 to 15.4	—	—	—	—
Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 Headache (Any)	36.4 Percentage of Participants Interval 17.2 to 59.3	40.9 Percentage of Participants Interval 20.7 to 63.6	50.0 Percentage of Participants Interval 28.2 to 71.8	—	—	—	—
Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 Headache (Mild)	31.8 Percentage of Participants Interval 13.9 to 54.9	18.2 Percentage of Participants Interval 5.2 to 40.3	31.8 Percentage of Participants Interval 13.9 to 54.9	—	—	—	—
Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 Headache (Moderate)	4.5 Percentage of Participants Interval 0.1 to 22.8	22.7 Percentage of Participants Interval 7.8 to 45.4	13.6 Percentage of Participants Interval 2.9 to 34.9	—	—	—	—
Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 Headache (Severe)	0 Percentage of Participants Interval 0.0 to 15.4	0 Percentage of Participants Interval 0.0 to 15.4	0 Percentage of Participants Interval 0.0 to 15.4	—	—	—	—
Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 Headache (Grade 4)	0 Percentage of Participants Interval 0.0 to 15.4	0 Percentage of Participants Interval 0.0 to 15.4	0 Percentage of Participants Interval 0.0 to 15.4	—	—	—	—
Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 Fatigue/tiredness (Any)	31.8 Percentage of Participants Interval 13.9 to 54.9	31.8 Percentage of Participants Interval 13.9 to 54.9	40.9 Percentage of Participants Interval 20.7 to 63.6	—	—	—	—
Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 Fatigue/tiredness (Mild)	18.2 Percentage of Participants Interval 5.2 to 40.3	22.7 Percentage of Participants Interval 7.8 to 45.4	31.8 Percentage of Participants Interval 13.9 to 54.9	—	—	—	—
Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 Fatigue/tiredness (Moderate)	13.6 Percentage of Participants Interval 2.9 to 34.9	9.1 Percentage of Participants Interval 1.1 to 29.2	9.1 Percentage of Participants Interval 1.1 to 29.2	—	—	—	—
Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 Fatigue/tiredness (Severe)	0 Percentage of Participants Interval 0.0 to 15.4	0 Percentage of Participants Interval 0.0 to 15.4	0 Percentage of Participants Interval 0.0 to 15.4	—	—	—	—
Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 Fatigue/tiredness (Grade 4)	0 Percentage of Participants Interval 0.0 to 15.4	0 Percentage of Participants Interval 0.0 to 15.4	0 Percentage of Participants Interval 0.0 to 15.4	—	—	—	—
Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 Muscle pain (Any)	4.5 Percentage of Participants Interval 0.1 to 22.8	22.7 Percentage of Participants Interval 7.8 to 45.4	22.7 Percentage of Participants Interval 7.8 to 45.4	—	—	—	—
Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 Muscle pain (Mild)	4.5 Percentage of Participants Interval 0.1 to 22.8	13.6 Percentage of Participants Interval 2.9 to 34.9	18.2 Percentage of Participants Interval 5.2 to 40.3	—	—	—	—
Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 Muscle pain (Moderate)	0 Percentage of Participants Interval 0.0 to 15.4	9.1 Percentage of Participants Interval 1.1 to 29.2	4.5 Percentage of Participants Interval 0.1 to 22.8	—	—	—	—
Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 Muscle pain (Severe)	0 Percentage of Participants Interval 0.0 to 15.4	0 Percentage of Participants Interval 0.0 to 15.4	0 Percentage of Participants Interval 0.0 to 15.4	—	—	—	—
Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 Muscle pain (Grade 4)	0 Percentage of Participants Interval 0.0 to 15.4	0 Percentage of Participants Interval 0.0 to 15.4	0 Percentage of Participants Interval 0.0 to 15.4	—	—	—	—
Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 Joint Pain (Any)	9.1 Percentage of Participants Interval 1.1 to 29.2	18.2 Percentage of Participants Interval 5.2 to 40.3	4.5 Percentage of Participants Interval 0.1 to 22.8	—	—	—	—
Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 Joint Pain (Mild)	9.1 Percentage of Participants Interval 1.1 to 29.2	13.6 Percentage of Participants Interval 2.9 to 34.9	4.5 Percentage of Participants Interval 0.1 to 22.8	—	—	—	—
Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 Joint Pain (Moderate)	0 Percentage of Participants Interval 0.0 to 15.4	4.5 Percentage of Participants Interval 0.1 to 22.8	0 Percentage of Participants Interval 0.0 to 15.4	—	—	—	—
Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 Joint Pain (Severe)	0 Percentage of Participants Interval 0.0 to 15.4	0 Percentage of Participants Interval 0.0 to 15.4	0 Percentage of Participants Interval 0.0 to 15.4	—	—	—	—
Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 Joint Pain (Grade 4)	0 Percentage of Participants Interval 0.0 to 15.4	0 Percentage of Participants Interval 0.0 to 15.4	0 Percentage of Participants Interval 0.0 to 15.4	—	—	—	—

PRIMARY outcome

Timeframe: Day 1 (day of vaccination) to Day 7 after booster dose

Population: Safety analysis set included all participants who received a booster dose of GBS6 vaccine or placebo.

Outcome measures

Outcome measures
Measure	Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) n=11 Participants Nonpregnant participants were randomized to receive a primary of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) n=7 Participants Nonpregnant participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 1: Placebo (Nonpregnant) n=8 Participants Non pregnant participants were randomized to receive placebo (saline control) intramuscularly on Day 1.	Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) Maternal participants were randomized to receive a single dose of 10 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg With AlPO4 (Maternal) Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: Placebo (Maternal) Maternal participants were randomized to receive placebo (saline control) intramuscularly on Day 1.
Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 Fever (38.0 deg C)	0 Percentage of Participants Interval 0.0 to 28.5	0 Percentage of Participants Interval 0.0 to 41.0	0 Percentage of Participants Interval 0.0 to 36.9	—	—	—	—
Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 Fever (38.0 to 38.4 deg C)	0 Percentage of Participants Interval 0.0 to 28.5	0 Percentage of Participants Interval 0.0 to 41.0	0 Percentage of Participants Interval 0.0 to 36.9	—	—	—	—
Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 Fever (38.5 to 38.9 deg C)	0 Percentage of Participants Interval 0.0 to 28.5	0 Percentage of Participants Interval 0.0 to 41.0	0 Percentage of Participants Interval 0.0 to 36.9	—	—	—	—
Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 Fever (39.0 to 40.0 deg C)	0 Percentage of Participants Interval 0.0 to 28.5	0 Percentage of Participants Interval 0.0 to 41.0	0 Percentage of Participants Interval 0.0 to 36.9	—	—	—	—
Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 Fever (>40.0 deg C)	0 Percentage of Participants Interval 0.0 to 28.5	0 Percentage of Participants Interval 0.0 to 41.0	0 Percentage of Participants Interval 0.0 to 36.9	—	—	—	—
Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 Nausea/vomiting (Any)	9.1 Percentage of Participants Interval 0.2 to 41.3	14.3 Percentage of Participants Interval 0.4 to 57.9	25.0 Percentage of Participants Interval 3.2 to 65.1	—	—	—	—
Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 Nausea/vomiting (Mild)	0 Percentage of Participants Interval 0.0 to 28.5	14.3 Percentage of Participants Interval 0.4 to 57.9	25.0 Percentage of Participants Interval 3.2 to 65.1	—	—	—	—
Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 Nausea/vomiting (Moderate)	9.1 Percentage of Participants Interval 0.2 to 41.3	0 Percentage of Participants Interval 0.0 to 41.0	0 Percentage of Participants Interval 0.0 to 36.9	—	—	—	—
Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 Nausea/vomiting (Severe)	0 Percentage of Participants Interval 0.0 to 28.5	0 Percentage of Participants Interval 0.0 to 41.0	0 Percentage of Participants Interval 0.0 to 36.9	—	—	—	—
Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 Nausea/vomiting (Grade 4)	0 Percentage of Participants Interval 0.0 to 28.5	0 Percentage of Participants Interval 0.0 to 41.0	0 Percentage of Participants Interval 0.0 to 36.9	—	—	—	—
Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 Diarrhea (Any)	18.2 Percentage of Participants Interval 2.3 to 51.8	0 Percentage of Participants Interval 0.0 to 41.0	12.5 Percentage of Participants Interval 0.3 to 52.7	—	—	—	—
Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 Diarrhea (Mild)	18.2 Percentage of Participants Interval 2.3 to 51.8	0 Percentage of Participants Interval 0.0 to 41.0	0 Percentage of Participants Interval 0.0 to 36.9	—	—	—	—
Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 Diarrhea (Moderate)	0 Percentage of Participants Interval 0.0 to 28.5	0 Percentage of Participants Interval 0.0 to 41.0	12.5 Percentage of Participants Interval 0.3 to 52.7	—	—	—	—
Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 Diarrhea (Severe)	0 Percentage of Participants Interval 0.0 to 28.5	0 Percentage of Participants Interval 0.0 to 41.0	0 Percentage of Participants Interval 0.0 to 36.9	—	—	—	—
Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 Diarrhea (Grade 4)	0 Percentage of Participants Interval 0.0 to 28.5	0 Percentage of Participants Interval 0.0 to 41.0	0 Percentage of Participants Interval 0.0 to 36.9	—	—	—	—
Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 Headache (Any)	27.3 Percentage of Participants Interval 6.0 to 61.0	14.3 Percentage of Participants Interval 0.4 to 57.9	62.5 Percentage of Participants Interval 24.5 to 91.5	—	—	—	—
Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 Headache (Mild)	0 Percentage of Participants Interval 0.0 to 28.5	14.3 Percentage of Participants Interval 0.4 to 57.9	25.0 Percentage of Participants Interval 3.2 to 65.1	—	—	—	—
Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 Headache (Moderate)	27.3 Percentage of Participants Interval 6.0 to 61.0	0 Percentage of Participants Interval 0.0 to 41.0	37.5 Percentage of Participants Interval 8.5 to 75.5	—	—	—	—
Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 Headache (Severe)	0 Percentage of Participants Interval 0.0 to 28.5	0 Percentage of Participants Interval 0.0 to 41.0	0 Percentage of Participants Interval 0.0 to 36.9	—	—	—	—
Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 Headache (Grade 4)	0 Percentage of Participants Interval 0.0 to 28.5	0 Percentage of Participants Interval 0.0 to 41.0	0 Percentage of Participants Interval 0.0 to 36.9	—	—	—	—
Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 Fatigue/tiredness (Any)	27.3 Percentage of Participants Interval 6.0 to 61.0	0 Percentage of Participants Interval 0.0 to 41.0	37.5 Percentage of Participants Interval 8.5 to 75.5	—	—	—	—
Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 Fatigue/tiredness (Mild)	9.1 Percentage of Participants Interval 0.2 to 41.3	0 Percentage of Participants Interval 0.0 to 41.0	0 Percentage of Participants Interval 0.0 to 36.9	—	—	—	—
Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 Fatigue/tiredness (Moderate)	18.2 Percentage of Participants Interval 2.3 to 51.8	0 Percentage of Participants Interval 0.0 to 41.0	37.5 Percentage of Participants Interval 8.5 to 75.5	—	—	—	—
Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 Fatigue/tiredness (Severe)	0 Percentage of Participants Interval 0.0 to 28.5	0 Percentage of Participants Interval 0.0 to 41.0	0 Percentage of Participants Interval 0.0 to 36.9	—	—	—	—
Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 Fatigue/tiredness (Grade 4)	0 Percentage of Participants Interval 0.0 to 28.5	0 Percentage of Participants Interval 0.0 to 41.0	0 Percentage of Participants Interval 0.0 to 36.9	—	—	—	—
Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 Muscle pain (Any)	9.1 Percentage of Participants Interval 0.2 to 41.3	0 Percentage of Participants Interval 0.0 to 41.0	37.5 Percentage of Participants Interval 8.5 to 75.5	—	—	—	—
Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 Muscle pain (Mild)	0 Percentage of Participants Interval 0.0 to 28.5	0 Percentage of Participants Interval 0.0 to 41.0	25.0 Percentage of Participants Interval 3.2 to 65.1	—	—	—	—
Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 Muscle pain (Moderate)	9.1 Percentage of Participants Interval 0.2 to 41.3	0 Percentage of Participants Interval 0.0 to 41.0	12.5 Percentage of Participants Interval 0.3 to 52.7	—	—	—	—
Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 Muscle pain (Severe)	0 Percentage of Participants Interval 0.0 to 28.5	0 Percentage of Participants Interval 0.0 to 41.0	0 Percentage of Participants Interval 0.0 to 36.9	—	—	—	—
Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 Muscle pain (Grade 4)	0 Percentage of Participants Interval 0.0 to 28.5	0 Percentage of Participants Interval 0.0 to 41.0	0 Percentage of Participants Interval 0.0 to 36.9	—	—	—	—
Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 Joint Pain (Any)	18.2 Percentage of Participants Interval 2.3 to 51.8	14.3 Percentage of Participants Interval 0.4 to 57.9	12.5 Percentage of Participants Interval 0.3 to 52.7	—	—	—	—
Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 Joint Pain (Mild)	0 Percentage of Participants Interval 0.0 to 28.5	14.3 Percentage of Participants Interval 0.4 to 57.9	0 Percentage of Participants Interval 0.0 to 36.9	—	—	—	—
Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 Joint Pain (Moderate)	18.2 Percentage of Participants Interval 2.3 to 51.8	0 Percentage of Participants Interval 0.0 to 41.0	12.5 Percentage of Participants Interval 0.3 to 52.7	—	—	—	—
Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 Joint Pain (Severe)	0 Percentage of Participants Interval 0.0 to 28.5	0 Percentage of Participants Interval 0.0 to 41.0	0 Percentage of Participants Interval 0.0 to 36.9	—	—	—	—
Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 Joint Pain (Grade 4)	0 Percentage of Participants Interval 0.0 to 28.5	0 Percentage of Participants Interval 0.0 to 41.0	0 Percentage of Participants Interval 0.0 to 36.9	—	—	—	—

PRIMARY outcome

Timeframe: Day 1 (day of vaccination) through 1 Month post primary dose

Population: Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.

Outcome measures

Outcome measures
Measure	Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) n=22 Participants Nonpregnant participants were randomized to receive a primary of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) n=22 Participants Nonpregnant participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 1: Placebo (Nonpregnant) n=22 Participants Non pregnant participants were randomized to receive placebo (saline control) intramuscularly on Day 1.	Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) Maternal participants were randomized to receive a single dose of 10 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg With AlPO4 (Maternal) Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: Placebo (Maternal) Maternal participants were randomized to receive placebo (saline control) intramuscularly on Day 1.
Percentage of Participants Reporting Adverse Events (AEs) Through 1 Month After Primary Dose: Non-Pregnant Participants Stage 1	54.5 Percentage of Participants Interval 32.2 to 75.6	45.5 Percentage of Participants Interval 24.4 to 67.8	36.4 Percentage of Participants Interval 17.2 to 59.3	—	—	—	—

PRIMARY outcome

Timeframe: Day 1 (day of vaccination) through 1 Month post booster dose

Population: Safety analysis set included all participants who received a booster dose of GBS6 vaccine or placebo.

Outcome measures

Outcome measures
Measure	Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) n=11 Participants Nonpregnant participants were randomized to receive a primary of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) n=7 Participants Nonpregnant participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 1: Placebo (Nonpregnant) n=8 Participants Non pregnant participants were randomized to receive placebo (saline control) intramuscularly on Day 1.	Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) Maternal participants were randomized to receive a single dose of 10 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg With AlPO4 (Maternal) Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: Placebo (Maternal) Maternal participants were randomized to receive placebo (saline control) intramuscularly on Day 1.
Percentage of Participants Reporting AEs Through 1 Month After Booster Dose: Non-Pregnant Participants Stage 1	18.2 Percentage of Participants Interval 2.3 to 51.8	0 Percentage of Participants Interval 0.0 to 41.0	12.5 Percentage of Participants Interval 0.3 to 52.7	—	—	—	—

PRIMARY outcome

Timeframe: Day 1 (day of vaccination) through 6 Months post primary dose

Population: Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.

Outcome measures

Outcome measures
Measure	Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) n=22 Participants Nonpregnant participants were randomized to receive a primary of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) n=22 Participants Nonpregnant participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 1: Placebo (Nonpregnant) n=22 Participants Non pregnant participants were randomized to receive placebo (saline control) intramuscularly on Day 1.	Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) Maternal participants were randomized to receive a single dose of 10 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg With AlPO4 (Maternal) Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: Placebo (Maternal) Maternal participants were randomized to receive placebo (saline control) intramuscularly on Day 1.
Percentage of Participants Reporting Medically Attended Adverse Events (MAEs) Through 6 Months After Primary Dose: Non-Pregnant Participants Stage 1	45.5 Percentage of Participants Interval 24.4 to 67.8	40.9 Percentage of Participants Interval 20.7 to 63.6	40.9 Percentage of Participants Interval 20.7 to 63.6	—	—	—	—

PRIMARY outcome

Timeframe: Day 1 (day of vaccination) through 6 Months post primary dose

Population: Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.

An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. Examples of AEs included but were not limited to abnormal test findings; clinically significant signs and symptoms; changes in physical examination findings; hypersensitivity; progression/worsening of underlying disease; drug abuse; drug dependency. A SAE was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); congenital anomaly/birth defect; or that was considered as an important medical event.

Outcome measures

Outcome measures
Measure	Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) n=22 Participants Nonpregnant participants were randomized to receive a primary of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) n=22 Participants Nonpregnant participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 1: Placebo (Nonpregnant) n=22 Participants Non pregnant participants were randomized to receive placebo (saline control) intramuscularly on Day 1.	Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) Maternal participants were randomized to receive a single dose of 10 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg With AlPO4 (Maternal) Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: Placebo (Maternal) Maternal participants were randomized to receive placebo (saline control) intramuscularly on Day 1.
Percentage of Participants Reporting Serious Adverse Events (SAEs) Through 6 Months After Primary Dose: Non-Pregnant Participants Stage 1	0 Percentage of Participants Interval 0.0 to 15.4	0 Percentage of Participants Interval 0.0 to 15.4	0 Percentage of Participants Interval 0.0 to 15.4	—	—	—	—

PRIMARY outcome

Timeframe: Day 1 (day of vaccination) through approximately 7 to 12 months post booster dose

Population: Safety analysis set included all participants who received a booster dose of GBS6 vaccine or placebo.

Outcome measures

Outcome measures
Measure	Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) n=11 Participants Nonpregnant participants were randomized to receive a primary of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) n=7 Participants Nonpregnant participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 1: Placebo (Nonpregnant) n=8 Participants Non pregnant participants were randomized to receive placebo (saline control) intramuscularly on Day 1.	Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) Maternal participants were randomized to receive a single dose of 10 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg With AlPO4 (Maternal) Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: Placebo (Maternal) Maternal participants were randomized to receive placebo (saline control) intramuscularly on Day 1.
Percentage of Participants Reporting MAEs Approximately 7 to 12 Months After Booster Dose: Non-Pregnant Participants Stage 1	0 Percentage of Participants Interval 0.0 to 28.5	14.3 Percentage of Participants Interval 0.4 to 57.9	25.0 Percentage of Participants Interval 3.2 to 65.1	—	—	—	—

PRIMARY outcome

Timeframe: Day 1 (day of vaccination) through approximately 7 to 12 months post booster dose

Population: Safety analysis set included all participants who received a booster dose of GBS6 vaccine or placebo.

Outcome measures

Outcome measures
Measure	Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) n=11 Participants Nonpregnant participants were randomized to receive a primary of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) n=7 Participants Nonpregnant participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 1: Placebo (Nonpregnant) n=8 Participants Non pregnant participants were randomized to receive placebo (saline control) intramuscularly on Day 1.	Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) Maternal participants were randomized to receive a single dose of 10 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg With AlPO4 (Maternal) Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: Placebo (Maternal) Maternal participants were randomized to receive placebo (saline control) intramuscularly on Day 1.
Percentage of Participants Reporting SAEs Approximately 7 to 12 Months After Booster Dose: Non-Pregnant Participants Stage 1	0 Percentage of Participants Interval 0.0 to 28.5	0 Percentage of Participants Interval 0.0 to 41.0	0 Percentage of Participants Interval 0.0 to 36.9	—	—	—	—

PRIMARY outcome

Timeframe: 2 weeks after vaccination in Stage 2

Population: Safety analysis set included all participants who received a dose of GBS6 vaccine or placebo. Here , number of participants analyzed signifies number of participants in the sentinel cohort (subset of Stage 2 maternal participants) evaluable for this outcome measure.

Hemoglobin: Grade 1, Platelets High: Grade 2, White blood cells decreased: Grade 1, Neutrophils (Absolute): Grade 1, Basophils (Absolute): Grade 2, Lymphocytes Low (Absolute): Grade1, Blood urea nitrogen (bun): Grade 1, Aspartate aminotransferase (AST): Grade 2, Alanine aminotransferase (ALT): Grade 1 and 3 and Alkaline phosphate: Grade 1. Grades were considered as 1: mild, 2: moderate, 3: severe. Only categories with non-zero values were reported for this outcome measure.

Outcome measures

Outcome measures
Measure	Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) n=13 Participants Nonpregnant participants were randomized to receive a primary of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) n=14 Participants Nonpregnant participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 1: Placebo (Nonpregnant) n=14 Participants Non pregnant participants were randomized to receive placebo (saline control) intramuscularly on Day 1.	Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) n=14 Participants Maternal participants were randomized to receive a single dose of 10 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg With AlPO4 (Maternal) n=14 Participants Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) n=12 Participants Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: Placebo (Maternal) n=42 Participants Maternal participants were randomized to receive placebo (saline control) intramuscularly on Day 1.
Number of Participants With Clinical Laboratory Abnormalities at 2 Week Follow-up Visit: Maternal Participants Stage 2 Alkaline phosphate Grade 1	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	8.3 Percentage of Participants	0 Percentage of Participants
Number of Participants With Clinical Laboratory Abnormalities at 2 Week Follow-up Visit: Maternal Participants Stage 2 White blood cells decreased Grade 1	15.4 Percentage of Participants	21.4 Percentage of Participants	7.1 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	8.3 Percentage of Participants	7.1 Percentage of Participants
Number of Participants With Clinical Laboratory Abnormalities at 2 Week Follow-up Visit: Maternal Participants Stage 2 Neutrophils (Absolute) Grade 1	7.7 Percentage of Participants	35.7 Percentage of Participants	7.1 Percentage of Participants	21.4 Percentage of Participants	7.1 Percentage of Participants	0 Percentage of Participants	9.5 Percentage of Participants
Number of Participants With Clinical Laboratory Abnormalities at 2 Week Follow-up Visit: Maternal Participants Stage 2 Basophils (Absolute) Grade 2	0 Percentage of Participants	0 Percentage of Participants	14.3 Percentage of Participants	21.4 Percentage of Participants	7.1 Percentage of Participants	0 Percentage of Participants	2.4 Percentage of Participants
Number of Participants With Clinical Laboratory Abnormalities at 2 Week Follow-up Visit: Maternal Participants Stage 2 Lymphocytes Low (Absolute) Grade 1	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	2.4 Percentage of Participants
Number of Participants With Clinical Laboratory Abnormalities at 2 Week Follow-up Visit: Maternal Participants Stage 2 Blood urea nitrogen Grade 1	1 Percentage of Participants	7.1 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Number of Participants With Clinical Laboratory Abnormalities at 2 Week Follow-up Visit: Maternal Participants Stage 2 Aspartate aminotransferase Grade 2	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	2.4 Percentage of Participants
Number of Participants With Clinical Laboratory Abnormalities at 2 Week Follow-up Visit: Maternal Participants Stage 2 Alanine aminotransferase Grade 1	0 Percentage of Participants	7.1 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Number of Participants With Clinical Laboratory Abnormalities at 2 Week Follow-up Visit: Maternal Participants Stage 2 Alanine aminotransferase Grade 3	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	2.4 Percentage of Participants
Number of Participants With Clinical Laboratory Abnormalities at 2 Week Follow-up Visit: Maternal Participants Stage 2 Hemoglobin Grade 1	0 Percentage of Participants	7.1 Percentage of Participants	0 Percentage of Participants	7.1 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	2.4 Percentage of Participants
Number of Participants With Clinical Laboratory Abnormalities at 2 Week Follow-up Visit: Maternal Participants Stage 2 Platelets High Grade 2	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	8.3 Percentage of Participants	0 Percentage of Participants

PRIMARY outcome

Timeframe: Day 1 (day of vaccination) to Day 7 after Vaccination

Population: Safety analysis set included all participants who received a dose of GBS6 vaccine or placebo. Here, number analyzed signifies participants who were evaluable for this outcome measure.

Local reactions (redness, swelling, and pain at the injection site of the left arm) were recorded by participants in e-diary. Erythema/Redness and induration/swelling were measured and recorded in measuring device units (1 measuring device unit=0.5 cm). Grading: Grade 1/mild (\> 2.5 to 5.0 cm), Grade 2/moderate (\>5.0 to 10.0 cm), Grade 3/severe (\>10.0 cm) and Grade 4 (necrosis \[swelling\] or necrosis or exfoliative dermatitis \[redness\]). Pain at injection site was graded as Grade 1/mild (did not interfere with activity), Grade2/moderate (interfered with activity), Grade 3/severe (prevented daily activity) and Grade 4 (ER visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person.

Outcome measures

Outcome measures
Measure	Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) n=40 Participants Nonpregnant participants were randomized to receive a primary of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) n=40 Participants Nonpregnant participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 1: Placebo (Nonpregnant) n=40 Participants Non pregnant participants were randomized to receive placebo (saline control) intramuscularly on Day 1.	Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) n=39 Participants Maternal participants were randomized to receive a single dose of 10 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg With AlPO4 (Maternal) n=40 Participants Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) n=40 Participants Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: Placebo (Maternal) n=120 Participants Maternal participants were randomized to receive placebo (saline control) intramuscularly on Day 1.
Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2 Pain at injection site (Any)	37.5 Percentage of Participants Interval 22.7 to 54.2	15.0 Percentage of Participants Interval 5.7 to 29.8	40.0 Percentage of Participants Interval 24.9 to 56.7	15.4 Percentage of Participants Interval 5.9 to 30.5	47.5 Percentage of Participants Interval 31.5 to 63.9	35.0 Percentage of Participants Interval 20.6 to 51.7	15.8 Percentage of Participants Interval 9.8 to 23.6
Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2 Pain at injection site (Mild)	32.5 Percentage of Participants Interval 18.6 to 49.1	12.5 Percentage of Participants Interval 4.2 to 26.8	35.0 Percentage of Participants Interval 20.6 to 51.7	15.4 Percentage of Participants Interval 5.9 to 30.5	42.5 Percentage of Participants Interval 27.0 to 59.1	20.0 Percentage of Participants Interval 9.1 to 35.6	12.5 Percentage of Participants Interval 7.2 to 19.8
Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2 Pain at injection site (Moderate)	5.0 Percentage of Participants Interval 0.6 to 16.9	2.5 Percentage of Participants Interval 0.1 to 13.2	5.0 Percentage of Participants Interval 0.6 to 16.9	0 Percentage of Participants Interval 0.0 to 9.0	5.0 Percentage of Participants Interval 0.6 to 16.9	15.0 Percentage of Participants Interval 5.7 to 29.8	3.3 Percentage of Participants Interval 0.9 to 8.3
Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2 Pain at injection site (Severe)	0 Percentage of Participants Interval 0.0 to 8.8	0 Percentage of Participants Interval 0.0 to 8.8	0 Percentage of Participants Interval 0.0 to 8.8	0 Percentage of Participants Interval 0.0 to 9.0	0 Percentage of Participants Interval 0.0 to 8.8	0 Percentage of Participants Interval 0.0 to 8.8	0 Percentage of Participants Interval 0.0 to 3.0
Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2 Pain at injection site (Grade 4)	0 Percentage of Participants Interval 0.0 to 8.8	0 Percentage of Participants Interval 0.0 to 8.8	0 Percentage of Participants Interval 0.0 to 8.8	0 Percentage of Participants Interval 0.0 to 9.0	0 Percentage of Participants Interval 0.0 to 8.8	0 Percentage of Participants Interval 0.0 to 8.8	0 Percentage of Participants Interval 0.0 to 3.0
Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2 Erythema/redness (Any)	0 Percentage of Participants Interval 0.0 to 8.8	0 Percentage of Participants Interval 0.0 to 8.8	2.5 Percentage of Participants Interval 0.01 to 13.2	0 Percentage of Participants Interval 0.0 to 9.0	2.5 Percentage of Participants Interval 0.1 to 13.2	2.5 Percentage of Participants Interval 0.1 to 13.2	1.7 Percentage of Participants Interval 0.2 to 5.9
Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2 Erythema/redness (Mild)	0 Percentage of Participants Interval 0.0 to 8.8	0 Percentage of Participants Interval 0.0 to 8.8	0 Percentage of Participants Interval 0.0 to 8.8	0 Percentage of Participants Interval 0.0 to 9.0	2.5 Percentage of Participants Interval 0.1 to 13.2	2.5 Percentage of Participants Interval 0.1 to 13.2	0.8 Percentage of Participants Interval 0.0 to 4.6
Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2 Erythema/redness (Moderate)	0 Percentage of Participants Interval 0.0 to 8.8	0 Percentage of Participants Interval 0.0 to 8.8	0 Percentage of Participants Interval 0.0 to 8.8	0 Percentage of Participants Interval 0.0 to 9.0	0 Percentage of Participants Interval 0.0 to 8.8	0 Percentage of Participants Interval 0.0 to 8.8	0.8 Percentage of Participants Interval 0.0 to 4.6
Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2 Erythema/redness (Severe)	0 Percentage of Participants Interval 0.0 to 8.8	0 Percentage of Participants Interval 0.0 to 8.8	2.5 Percentage of Participants Interval 0.1 to 13.2	0 Percentage of Participants Interval 0.0 to 9.0	0 Percentage of Participants Interval 0.0 to 8.8	0 Percentage of Participants Interval 0.0 to 8.8	0 Percentage of Participants Interval 0.0 to 3.0
Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2 Erythema/redness (Grade 4)	0 Percentage of Participants Interval 0.0 to 8.8	0 Percentage of Participants Interval 0.0 to 8.8	0 Percentage of Participants Interval 0.0 to 8.8	0 Percentage of Participants Interval 0.0 to 9.0	0 Percentage of Participants Interval 0.0 to 8.8	0 Percentage of Participants Interval 0.0 to 8.8	0 Percentage of Participants Interval 0.0 to 3.0
Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2 Induration/swelling (Any)	0 Percentage of Participants Interval 0.0 to 8.8	2.5 Percentage of Participants Interval 0.1 to 13.2	2.5 Percentage of Participants Interval 0.1 to 13.2	2.6 Percentage of Participants Interval 0.1 to 13.5	5.0 Percentage of Participants Interval 0.6 to 16.9	2.5 Percentage of Participants Interval 0.1 to 13.2	0.8 Percentage of Participants Interval 0.0 to 4.6
Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2 Induration/swelling (Mild)	0 Percentage of Participants Interval 0.0 to 8.8	2.5 Percentage of Participants Interval 0.1 to 13.2	0 Percentage of Participants Interval 0.0 to 8.8	2.6 Percentage of Participants Interval 0.1 to 13.5	5.0 Percentage of Participants Interval 0.6 to 16.9	2.5 Percentage of Participants Interval 0.1 to 13.2	0 Percentage of Participants Interval 0.0 to 3.0
Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2 Induration/swelling (Moderate)	0 Percentage of Participants Interval 0.0 to 8.8	0 Percentage of Participants Interval 0.0 to 8.8	0 Percentage of Participants Interval 0.0 to 8.8	0 Percentage of Participants Interval 0.0 to 9.0	0 Percentage of Participants Interval 0.0 to 8.8	0 Percentage of Participants Interval 0.0 to 8.8	0.8 Percentage of Participants Interval 0.0 to 4.6
Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2 Induration/swelling (Severe)	0 Percentage of Participants Interval 0.0 to 8.8	0 Percentage of Participants Interval 0.0 to 8.8	2.5 Percentage of Participants Interval 0.1 to 13.2	0 Percentage of Participants Interval 0.0 to 9.0	0 Percentage of Participants Interval 0.0 to 8.8	0 Percentage of Participants Interval 0.0 to 8.8	0 Percentage of Participants Interval 0.0 to 3.0
Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2 Induration/swelling (Grade 4)	0 Percentage of Participants Interval 0.0 to 8.8	0 Percentage of Participants Interval 0.0 to 8.8	0 Percentage of Participants Interval 0.0 to 8.8	0 Percentage of Participants Interval 0.0 to 9.0	0 Percentage of Participants Interval 0.0 to 8.8	0 Percentage of Participants Interval 0.0 to 8.8	0 Percentage of Participants Interval 0.0 to 3.0

PRIMARY outcome

Timeframe: Day 1 (day of vaccination) to Day 7 after Vaccination

Population: Safety analysis set included all participants who received a dose of GBS6 vaccine or placebo. Here, number analyzed signifies participants who were evaluable for this outcome measure.

Local reactions (redness, swelling, and pain at the injection site of the left arm) were recorded by participants in e-diary. Erythema/Redness and induration/swelling were measured and recorded in measuring device units (1 measuring device unit=0.5 cm). Grading: Grade 1/mild (\> 2.5 to 5.0 cm), Grade 2/moderate (\>5.0 to 10.0 cm), Grade 3/severe (\>10.0 cm) and Grade 4 (necrosis \[swelling\] or necrosis or exfoliative dermatitis \[redness\]). Pain at injection site was graded as Grade 1/mild (did not interfere with activity), Grade2/moderate (interfered with activity), Grade 3/severe (prevented daily activity) and Grade 4 (ER visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person.

Outcome measures

Outcome measures
Measure	Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) n=106 Participants Nonpregnant participants were randomized to receive a primary of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) n=103 Participants Nonpregnant participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 1: Placebo (Nonpregnant) Non pregnant participants were randomized to receive placebo (saline control) intramuscularly on Day 1.	Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) Maternal participants were randomized to receive a single dose of 10 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg With AlPO4 (Maternal) Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: Placebo (Maternal) Maternal participants were randomized to receive placebo (saline control) intramuscularly on Day 1.
Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 3 Pain at injection site (Any)	30.2 Percentage of Participants Interval 21.7 to 39.9	18.4 Percentage of Participants Interval 11.5 to 27.3	—	—	—	—	—
Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 3 Pain at injection site (Mild)	25.5 Percentage of Participants Interval 17.5 to 34.9	13.6 Percentage of Participants Interval 7.6 to 21.8	—	—	—	—	—
Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 3 Pain at injection site (Moderate)	4.7 Percentage of Participants Interval 1.5 to 10.7	4.9 Percentage of Participants Interval 1.6 to 11.0	—	—	—	—	—
Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 3 Pain at injection site (Severe)	0 Percentage of Participants Interval 0.0 to 3.4	0 Percentage of Participants Interval 0.0 to 3.5	—	—	—	—	—
Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 3 Pain at injection site (Grade 4)	0 Percentage of Participants Interval 0.0 to 3.4	0 Percentage of Participants Interval 0.0 to 3.5	—	—	—	—	—
Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 3 Erythema/redness (Any)	0 Percentage of Participants Interval 0.0 to 3.4	0 Percentage of Participants Interval 0.0 to 3.5	—	—	—	—	—
Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 3 Erythema/redness (Mild)	0 Percentage of Participants Interval 0.0 to 3.4	0 Percentage of Participants Interval 0.0 to 3.5	—	—	—	—	—
Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 3 Erythema/redness (Moderate)	0 Percentage of Participants Interval 0.0 to 3.4	0 Percentage of Participants Interval 0.0 to 3.5	—	—	—	—	—
Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 3 Erythema/redness (Severe)	0 Percentage of Participants Interval 0.0 to 3.4	0 Percentage of Participants Interval 0.0 to 3.5	—	—	—	—	—
Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 3 Erythema/redness (Grade 4)	0 Percentage of Participants Interval 0.0 to 3.4	0 Percentage of Participants Interval 0.0 to 3.5	—	—	—	—	—
Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 3 Induration/swelling (Any)	0 Percentage of Participants Interval 0.0 to 3.4	0 Percentage of Participants Interval 0.0 to 3.5	—	—	—	—	—
Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 3 Induration/swelling (Mild)	0 Percentage of Participants Interval 0.0 to 3.4	0 Percentage of Participants Interval 0.0 to 3.5	—	—	—	—	—
Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 3 Induration/swelling (Moderate)	0 Percentage of Participants Interval 0.0 to 3.4	0 Percentage of Participants Interval 0.0 to 3.5	—	—	—	—	—
Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 3 Induration/swelling (Severe)	0 Percentage of Participants Interval 0.0 to 3.4	0 Percentage of Participants Interval 0.0 to 3.5	—	—	—	—	—
Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 3 Induration/swelling (Grade 4)	0 Percentage of Participants Interval 0.0 to 3.4	0 Percentage of Participants Interval 0.0 to 3.5	—	—	—	—	—

PRIMARY outcome

Timeframe: Day 1 (day of vaccination) to Day 7 after Vaccination

Population: Safety analysis set included all participants who received a dose of GBS6 vaccine or placebo. Here, number analyzed signifies participants who were evaluable for this outcome measure.

Systemic events were recorded in e-diary. Fever: oral temperature \>=38.0 deg C and categorized as \>=38.0-38.4 deg C, \>38.4-38.9 deg C, \>38.9-40.0 deg C and \>40.0 deg C. Nausea/vomiting was graded as: Grade 1/mild (1-2 times in 24 h), Grade 2/moderate: (\>2 times in 24h), Grade 3/severe (required intravenous hydration) and Grade 4 (ER visit/hospitalization for hypotensive shock). Diarrhea was graded as: Grade 1/mild (2-3 loose stools in 24h), Grade 2/moderate (4-5 loose stools in 24h), Grade 3/severe (6 or more loose stools in 24h) and Grade 4 (ER visit/hospitalization for severe diarrhea). Fatigue/tiredness, headache, muscle pain and joint pain were graded as: Grade 1/mild (did not interfere with activity), Grade 2/moderate (some interference with activity), Grade 3/severe (prevented daily routine activity) and Grade 4 (ER visit/hospitalization). Grade 4 were classified by investigator or medically qualified person.

Outcome measures

Outcome measures
Measure	Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) n=40 Participants Nonpregnant participants were randomized to receive a primary of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) n=40 Participants Nonpregnant participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 1: Placebo (Nonpregnant) n=40 Participants Non pregnant participants were randomized to receive placebo (saline control) intramuscularly on Day 1.	Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) n=39 Participants Maternal participants were randomized to receive a single dose of 10 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg With AlPO4 (Maternal) n=40 Participants Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) n=40 Participants Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: Placebo (Maternal) n=120 Participants Maternal participants were randomized to receive placebo (saline control) intramuscularly on Day 1.
Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 Fever (>=38.0 deg C)	2.5 Percentage of Participants Interval 0.1 to 13.2	5.0 Percentage of Participants Interval 0.6 to 16.9	2.5 Percentage of Participants Interval 0.1 to 13.2	7.7 Percentage of Participants Interval 1.6 to 20.9	2.5 Percentage of Participants Interval 0.1 to 13.2	5.0 Percentage of Participants Interval 0.6 to 16.9	5.0 Percentage of Participants Interval 1.9 to 10.6
Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 Fever (38.0 to 38.4 deg C)	2.5 Percentage of Participants Interval 0.1 to 13.2	0 Percentage of Participants Interval 0.0 to 8.8	2.5 Percentage of Participants Interval 0.1 to 13.2	5.1 Percentage of Participants Interval 0.6 to 17.3	0 Percentage of Participants Interval 0.0 to 8.8	2.5 Percentage of Participants Interval 0.1 to 13.2	3.3 Percentage of Participants Interval 0.9 to 8.3
Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 Fever (38.5 to 38.9 deg C)	0 Percentage of Participants Interval 0.0 to 8.8	5.0 Percentage of Participants Interval 0.6 to 16.9	0 Percentage of Participants Interval 0.0 to 8.8	0 Percentage of Participants Interval 0.0 to 9.0	0 Percentage of Participants Interval 0.0 to 8.8	2.5 Percentage of Participants Interval 0.1 to 13.2	1.7 Percentage of Participants Interval 0.2 to 5.9
Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 Fever (39.0 to 40.0 deg C)	0 Percentage of Participants Interval 0.0 to 8.8	0 Percentage of Participants Interval 0.0 to 8.8	0 Percentage of Participants Interval 0.0 to 8.8	2.6 Percentage of Participants Interval 0.1 to 13.5	2.5 Percentage of Participants Interval 0.1 to 13.2	0 Percentage of Participants Interval 0.0 to 8.8	0 Percentage of Participants Interval 0.0 to 3.0
Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 Fever (>40.0 deg C)	0 Percentage of Participants Interval 0.0 to 8.8	0 Percentage of Participants Interval 0.0 to 8.8	0 Percentage of Participants Interval 0.0 to 8.8	0 Percentage of Participants Interval 0.0 to 9.0	0 Percentage of Participants Interval 0.0 to 8.8	0 Percentage of Participants Interval 0.0 to 8.8	0 Percentage of Participants Interval 0.0 to 3.0
Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 Nausea/vomiting (Any)	15.0 Percentage of Participants Interval 5.7 to 29.8	7.5 Percentage of Participants Interval 1.6 to 20.4	20.0 Percentage of Participants Interval 9.1 to 35.6	15.4 Percentage of Participants Interval 5.9 to 30.5	15.0 Percentage of Participants Interval 5.7 to 29.8	22.5 Percentage of Participants Interval 10.8 to 38.5	26.7 Percentage of Participants Interval 19.0 to 35.5
Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 Nausea/vomiting (Mild)	10.0 Percentage of Participants Interval 2.8 to 23.7	5.0 Percentage of Participants Interval 0.6 to 16.9	17.5 Percentage of Participants Interval 7.3 to 32.8	10.3 Percentage of Participants Interval 2.9 to 242.0	12.5 Percentage of Participants Interval 4.2 to 26.8	17.5 Percentage of Participants Interval 7.3 to 32.8	19.2 Percentage of Participants Interval 12.6 to 27.4
Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 Nausea/vomiting (Moderate)	5.0 Percentage of Participants Interval 0.6 to 16.9	2.5 Percentage of Participants Interval 0.1 to 13.2	2.5 Percentage of Participants Interval 0.1 to 13.2	5.1 Percentage of Participants Interval 0.6 to 17.3	2.5 Percentage of Participants Interval 0.1 to 13.2	5.0 Percentage of Participants Interval 0.6 to 16.9	7.5 Percentage of Participants Interval 3.5 to 13.8
Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 Nausea/vomiting (Severe)	0 Percentage of Participants Interval 0.0 to 8.8	0 Percentage of Participants Interval 0.0 to 8.8	0 Percentage of Participants Interval 0.0 to 8.8	0 Percentage of Participants Interval 0.0 to 9.0	0 Percentage of Participants Interval 0.0 to 8.8	0 Percentage of Participants Interval 0.0 to 8.8	0 Percentage of Participants Interval 0.0 to 3.0
Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 Nausea/vomiting (Grade 4)	0 Percentage of Participants Interval 0.0 to 8.8	0 Percentage of Participants Interval 0.0 to 8.8	0 Percentage of Participants Interval 0.0 to 8.8	0 Percentage of Participants Interval 0.0 to 9.0	0 Percentage of Participants Interval 0.0 to 8.8	0 Percentage of Participants Interval 0.0 to 8.8	0 Percentage of Participants Interval 0.0 to 3.0
Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 Diarrhea (Any)	5.0 Percentage of Participants Interval 0.6 to 16.9	17.5 Percentage of Participants Interval 7.3 to 32.8	10.0 Percentage of Participants Interval 2.8 to 23.7	23.1 Percentage of Participants Interval 11.1 to 39.3	7.5 Percentage of Participants Interval 1.6 to 20.4	10.0 Percentage of Participants Interval 2.8 to 23.7	16.7 Percentage of Participants Interval 10.5 to 24.6
Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 Diarrhea (Mild)	5.0 Percentage of Participants Interval 0.6 to 16.9	12.5 Percentage of Participants Interval 4.2 to 26.8	7.5 Percentage of Participants Interval 1.6 to 20.4	7.7 Percentage of Participants Interval 1.6 to 20.9	7.5 Percentage of Participants Interval 1.6 to 20.4	10.0 Percentage of Participants Interval 2.8 to 23.7	15.0 Percentage of Participants Interval 9.1 to 22.7
Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 Diarrhea (Moderate)	0 Percentage of Participants Interval 0.0 to 8.8	5.0 Percentage of Participants Interval 0.6 to 16.9	2.5 Percentage of Participants Interval 0.1 to 13.2	12.8 Percentage of Participants Interval 4.3 to 27.4	0 Percentage of Participants Interval 0.0 to 8.8	0 Percentage of Participants Interval 0.0 to 8.8	0.8 Percentage of Participants Interval 0.0 to 4.6
Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 Diarrhea (Severe)	0 Percentage of Participants Interval 0.0 to 8.8	0 Percentage of Participants Interval 0.0 to 8.8	0 Percentage of Participants Interval 0.0 to 8.8	2.6 Percentage of Participants Interval 0.1 to 13.5	0 Percentage of Participants Interval 0.0 to 8.8	0 Percentage of Participants Interval 0.0 to 8.8	0.8 Percentage of Participants Interval 0.0 to 4.6
Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 Diarrhea (Grade 4)	0 Percentage of Participants Interval 0.0 to 8.8	0 Percentage of Participants Interval 0.0 to 8.8	0 Percentage of Participants Interval 0.0 to 8.8	0 Percentage of Participants Interval 0.0 to 9.0	0 Percentage of Participants Interval 0.0 to 8.8	0 Percentage of Participants Interval 0.0 to 8.8	0 Percentage of Participants Interval 0.0 to 3.0
Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 Headache (Any)	30.0 Percentage of Participants Interval 16.6 to 46.5	47.5 Percentage of Participants Interval 31.5 to 63.9	30.0 Percentage of Participants Interval 16.6 to 46.5	33.3 Percentage of Participants Interval 19.1 to 50.2	32.5 Percentage of Participants Interval 18.6 to 49.1	40.0 Percentage of Participants Interval 24.9 to 56.7	33.3 Percentage of Participants Interval 25.0 to 42.5
Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 Headache (Mild)	22.5 Percentage of Participants Interval 10.8 to 38.5	37.5 Percentage of Participants Interval 22.7 to 54.2	15.0 Percentage of Participants Interval 5.7 to 29.8	17.9 Percentage of Participants Interval 7.5 to 33.5	25.0 Percentage of Participants Interval 12.7 to 41.2	22.5 Percentage of Participants Interval 10.8 to 38.5	25.0 Percentage of Participants Interval 17.5 to 33.7
Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 Headache (Moderate)	7.5 Percentage of Participants Interval 1.6 to 20.4	10.0 Percentage of Participants Interval 2.8 to 23.7	15.0 Percentage of Participants Interval 5.7 to 29.8	15.4 Percentage of Participants Interval 5.9 to 30.5	7.5 Percentage of Participants Interval 1.6 to 20.4	17.5 Percentage of Participants Interval 7.3 to 32.8	7.5 Percentage of Participants Interval 3.5 to 13.8
Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 Headache (Severe)	0 Percentage of Participants Interval 0.0 to 8.8	0 Percentage of Participants Interval 0.0 to 8.8	0 Percentage of Participants Interval 0.0 to 8.8	0 Percentage of Participants Interval 0.0 to 9.0	0 Percentage of Participants Interval 0.0 to 8.8	0 Percentage of Participants Interval 0.0 to 8.8	0.8 Percentage of Participants Interval 0.0 to 4.6
Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 Headache (Grade 4)	0 Percentage of Participants Interval 0.0 to 8.8	0 Percentage of Participants Interval 0.0 to 8.8	0 Percentage of Participants Interval 0.0 to 8.8	0 Percentage of Participants Interval 0.0 to 9.0	0 Percentage of Participants Interval 0.0 to 8.8	0 Percentage of Participants Interval 0.0 to 8.8	0 Percentage of Participants Interval 0.0 to 3.0
Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 Fatigue/tiredness (Any)	37.5 Percentage of Participants Interval 22.7 to 54.2	45.0 Percentage of Participants Interval 29.3 to 61.5	37.5 Percentage of Participants Interval 22.7 to 54.2	38.5 Percentage of Participants Interval 23.4 to 55.4	47.5 Percentage of Participants Interval 31.5 to 63.9	42.5 Percentage of Participants Interval 27.0 to 59.1	40.0 Percentage of Participants Interval 31.2 to 49.3
Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 Fatigue/tiredness (Mild)	27.5 Percentage of Participants Interval 14.6 to 43.9	22.5 Percentage of Participants Interval 10.8 to 38.5	25.0 Percentage of Participants Interval 12.7 to 41.2	17.9 Percentage of Participants Interval 7.5 to 33.5	35.0 Percentage of Participants Interval 20.6 to 51.7	30.0 Percentage of Participants Interval 16.6 to 46.5	23.3 Percentage of Participants Interval 16.1 to 31.9
Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 Fatigue/tiredness (Moderate)	10.0 Percentage of Participants Interval 2.8 to 23.7	22.5 Percentage of Participants Interval 10.8 to 38.5	12.5 Percentage of Participants Interval 4.2 to 26.8	17.9 Percentage of Participants Interval 7.5 to 33.5	10.0 Percentage of Participants Interval 2.8 to 23.7	12.5 Percentage of Participants Interval 4.2 to 26.8	14.2 Percentage of Participants Interval 8.5 to 21.7
Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 Fatigue/tiredness (Severe)	0 Percentage of Participants Interval 0.0 to 8.8	0 Percentage of Participants Interval 0.0 to 8.8	0 Percentage of Participants Interval 0.0 to 8.8	2.6 Percentage of Participants Interval 0.1 to 13.5	2.5 Percentage of Participants Interval 0.1 to 13.2	0 Percentage of Participants Interval 0.0 to 8.8	2.5 Percentage of Participants Interval 0.5 to 7.1
Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 Fatigue/tiredness (Grade 4)	0 Percentage of Participants Interval 0.0 to 8.8	0 Percentage of Participants Interval 0.0 to 8.8	0 Percentage of Participants Interval 0.0 to 8.8	0 Percentage of Participants Interval 0.0 to 9.0	0 Percentage of Participants Interval 0.0 to 8.8	0 Percentage of Participants Interval 0.0 to 8.8	0 Percentage of Participants Interval 0.0 to 3.0
Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 Muscle pain (Any)	12.5 Percentage of Participants Interval 4.2 to 26.8	25.0 Percentage of Participants Interval 12.7 to 41.2	17.5 Percentage of Participants Interval 7.3 to 32.8	15.4 Percentage of Participants Interval 5.9 to 30.5	17.5 Percentage of Participants Interval 7.3 to 32.8	25.0 Percentage of Participants Interval 12.7 to 41.2	15.8 Percentage of Participants Interval 9.8 to 23.6
Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 Muscle pain (Mild)	7.5 Percentage of Participants Interval 1.6 to 20.4	12.5 Percentage of Participants Interval 4.2 to 26.8	15.0 Percentage of Participants Interval 5.7 to 29.8	10.3 Percentage of Participants Interval 2.9 to 24.2	12.5 Percentage of Participants Interval 4.2 to 26.8	12.5 Percentage of Participants Interval 4.2 to 26.8	10.8 Percentage of Participants Interval 5.9 to 17.8
Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 Muscle pain (Moderate)	5.0 Percentage of Participants Interval 0.6 to 16.9	12.5 Percentage of Participants Interval 4.2 to 26.8	2.5 Percentage of Participants Interval 0.1 to 13.2	5.1 Percentage of Participants Interval 0.6 to 17.3	2.5 Percentage of Participants Interval 0.1 to 13.2	12.5 Percentage of Participants Interval 4.2 to 26.8	5.0 Percentage of Participants Interval 1.9 to 10.6
Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 Muscle pain (Severe)	0 Percentage of Participants Interval 0.0 to 8.8	0 Percentage of Participants Interval 0.0 to 8.8	0 Percentage of Participants Interval 0.0 to 8.8	0 Percentage of Participants Interval 0.0 to 9.0	2.5 Percentage of Participants Interval 0.1 to 13.2	0 Percentage of Participants Interval 0.0 to 8.8	0 Percentage of Participants Interval 0.0 to 3.0
Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 Muscle pain (Grade 4)	0 Percentage of Participants Interval 0.0 to 8.8	0 Percentage of Participants Interval 0.0 to 8.8	0 Percentage of Participants Interval 0.0 to 8.8	0 Percentage of Participants Interval 0.0 to 8.8	0 Percentage of Participants Interval 0.0 to 8.8	0 Percentage of Participants Interval 0.0 to 8.8	0 Percentage of Participants Interval 0.0 to 3.0
Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 Joint pain (Any)	10.0 Percentage of Participants Interval 2.8 to 23.7	10.0 Percentage of Participants Interval 2.8 to 23.7	2.5 Percentage of Participants Interval 0.1 to 13.2	12.8 Percentage of Participants Interval 4.3 to 27.4	15.0 Percentage of Participants Interval 5.7 to 29.8	20.0 Percentage of Participants Interval 9.1 to 35.6	16.7 Percentage of Participants Interval 10.5 to 24.6
Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 Joint pain (Mild)	7.5 Percentage of Participants Interval 1.6 to 20.4	2.5 Percentage of Participants Interval 0.1 to 13.2	2.5 Percentage of Participants Interval 0.1 to 13.2	7.7 Percentage of Participants Interval 1.6 to 20.9	10.0 Percentage of Participants Interval 2.8 to 23.7	10.0 Percentage of Participants Interval 2.8 to 23.7	11.7 Percentage of Participants Interval 6.5 to 18.8
Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 Joint pain (Moderate)	2.5 Percentage of Participants Interval 0.1 to 13.2	7.5 Percentage of Participants Interval 1.6 to 20.4	0 Percentage of Participants Interval 0.0 to 8.8	5.1 Percentage of Participants Interval 0.6 to 17.3	2.5 Percentage of Participants Interval 0.1 to 13.2	10.0 Percentage of Participants Interval 2.8 to 23.7	5.0 Percentage of Participants Interval 1.9 to 10.6
Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 Joint pain (Severe)	0 Percentage of Participants Interval 0.0 to 8.8	0 Percentage of Participants Interval 0.0 to 8.8	0 Percentage of Participants Interval 0.0 to 8.8	0 Percentage of Participants Interval 0.0 to 9.0	2.5 Percentage of Participants Interval 0.1 to 13.2	0 Percentage of Participants Interval 0.0 to 8.8	0 Percentage of Participants Interval 0.0 to 3.0
Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 Joint pain (Grade 4)	0 Percentage of Participants Interval 0.0 to 8.8	0 Percentage of Participants Interval 0.0 to 8.8	0 Percentage of Participants Interval 0.0 to 8.8	0 Percentage of Participants Interval 0.0 to 9.0	0 Percentage of Participants Interval 0.0 to 8.8	0 Percentage of Participants Interval 0.0 to 8.8	0 Percentage of Participants Interval 0.0 to 3.0

PRIMARY outcome

Timeframe: Day 1 (day of vaccination) to Day 7 after Vaccination

Population: Safety analysis set included all participants who received a dose of GBS6 vaccine or placebo. Here, number analyzed signifies participants who were evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) n=106 Participants Nonpregnant participants were randomized to receive a primary of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) n=103 Participants Nonpregnant participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 1: Placebo (Nonpregnant) Non pregnant participants were randomized to receive placebo (saline control) intramuscularly on Day 1.	Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) Maternal participants were randomized to receive a single dose of 10 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg With AlPO4 (Maternal) Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: Placebo (Maternal) Maternal participants were randomized to receive placebo (saline control) intramuscularly on Day 1.
Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 3 Muscle pain (Grade 4)	0 Percentage of Participants Interval 0.0 to 3.4	0 Percentage of Participants Interval 0.0 to 3.5	—	—	—	—	—
Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 3 Joint pain (Any)	15.1 Percentage of Participants Interval 8.9 to 23.4	13.6 Percentage of Participants Interval 7.6 to 21.8	—	—	—	—	—
Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 3 Joint pain (Mild)	9.4 Percentage of Participants Interval 4.6 to 16.7	8.7 Percentage of Participants Interval 4.1 to 15.9	—	—	—	—	—
Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 3 Joint pain (Moderate)	5.7 Percentage of Participants Interval 2.1 to 11.9	3.9 Percentage of Participants Interval 1.1 to 9.6	—	—	—	—	—
Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 3 Joint pain (Severe)	0 Percentage of Participants Interval 0.0 to 3.4	1.0 Percentage of Participants Interval 0.0 to 5.3	—	—	—	—	—
Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 3 Joint pain (Grade 4)	0 Percentage of Participants Interval 0.0 to 3.4	0 Percentage of Participants Interval 0.0 to 3.5	—	—	—	—	—
Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 3 Fever (>=38.0 deg C)	2.8 Percentage of Participants Interval 0.6 to 8.0	4.9 Percentage of Participants Interval 1.6 to 11.0	—	—	—	—	—
Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 3 Fever (38.0 to 38.4 deg C)	2.8 Percentage of Participants Interval 0.6 to 8.0	2.9 Percentage of Participants Interval 0.6 to 8.3	—	—	—	—	—
Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 3 Fever (38.5 to 38.9 deg C)	0 Percentage of Participants Interval 0.0 to 3.4	1.9 Percentage of Participants Interval 0.2 to 6.8	—	—	—	—	—
Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 3 Fever (39.0 to 40.0 deg C)	0 Percentage of Participants Interval 0.0 to 3.4	0 Percentage of Participants Interval 0.0 to 3.5	—	—	—	—	—
Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 3 Fever (>40.0 deg C)	0 Percentage of Participants Interval 0.0 to 3.4	0 Percentage of Participants Interval 0.0 to 3.5	—	—	—	—	—
Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 3 Nausea/vomiting (Any)	21.7 Percentage of Participants Interval 14.3 to 30.8	29.1 Percentage of Participants Interval 20.6 to 38.9	—	—	—	—	—
Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 3 Nausea/vomiting (Mild)	18.9 Percentage of Participants Interval 11.9 to 27.6	22.3 Percentage of Participants Interval 14.7 to 31.6	—	—	—	—	—
Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 3 Nausea/vomiting (Moderate)	2.8 Percentage of Participants Interval 0.6 to 8.0	6.8 Percentage of Participants Interval 2.8 to 13.5	—	—	—	—	—
Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 3 Nausea/vomiting (Severe)	0 Percentage of Participants Interval 0.0 to 3.4	0 Percentage of Participants Interval 0.0 to 3.5	—	—	—	—	—
Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 3 Nausea/vomiting (Grade 4)	0 Percentage of Participants Interval 0.0 to 3.4	0 Percentage of Participants Interval 0.0 to 3.5	—	—	—	—	—
Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 3 Diarrhea (Any)	12.3 Percentage of Participants Interval 6.7 to 20.1	11.7 Percentage of Participants Interval 6.2 to 19.5	—	—	—	—	—
Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 3 Diarrhea (Mild)	12.3 Percentage of Participants Interval 6.7 to 20.1	8.7 Percentage of Participants Interval 4.1 to 15.9	—	—	—	—	—
Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 3 Diarrhea (Moderate)	0 Percentage of Participants Interval 0.0 to 3.4	2.9 Percentage of Participants Interval 0.6 to 8.3	—	—	—	—	—
Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 3 Diarrhea (Severe)	0 Percentage of Participants Interval 0.0 to 3.4	0 Percentage of Participants Interval 0.0 to 3.5	—	—	—	—	—
Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 3 Diarrhea (Grade 4)	0 Percentage of Participants Interval 0.0 to 3.4	0 Percentage of Participants Interval 0.0 to 3.5	—	—	—	—	—
Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 3 Headache (Any)	36.8 Percentage of Participants Interval 27.6 to 46.7	37.9 Percentage of Participants Interval 28.5 to 48.0	—	—	—	—	—
Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 3 Headache (Mild)	19.8 Percentage of Participants Interval 12.7 to 28.7	30.1 Percentage of Participants Interval 21.5 to 39.9	—	—	—	—	—
Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 3 Headache (Moderate)	17.0 Percentage of Participants Interval 10.4 to 25.5	7.8 Percentage of Participants Interval 3.4 to 14.7	—	—	—	—	—
Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 3 Headache (Severe)	0 Percentage of Participants Interval 0.0 to 3.4	0 Percentage of Participants Interval 0.0 to 3.5	—	—	—	—	—
Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 3 Headache (Grade 4)	0 Percentage of Participants Interval 0.0 to 3.4	0 Percentage of Participants Interval 0.0 to 3.5	—	—	—	—	—
Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 3 Fatigue/tiredness (Any)	42.5 Percentage of Participants Interval 32.9 to 52.4	42.7 Percentage of Participants Interval 33.0 to 52.8	—	—	—	—	—
Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 3 Fatigue/tiredness (Mild)	24.5 Percentage of Participants Interval 16.7 to 33.8	24.3 Percentage of Participants Interval 16.4 to 33.7	—	—	—	—	—
Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 3 Fatigue/tiredness (Moderate)	17.9 Percentage of Participants Interval 11.2 to 26.6	15.5 Percentage of Participants Interval 9.1 to 24.0	—	—	—	—	—
Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 3 Fatigue/tiredness (Severe)	0 Percentage of Participants Interval 0.0 to 3.4	2.9 Percentage of Participants Interval 0.6 to 8.3	—	—	—	—	—
Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 3 Fatigue/tiredness (Grade 4)	0 Percentage of Participants Interval 0.0 to 3.4	0 Percentage of Participants Interval 0.0 to 3.5	—	—	—	—	—
Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 3 Muscle pain (Any)	18.9 Percentage of Participants Interval 11.9 to 27.6	14.6 Percentage of Participants Interval 8.4 to 22.9	—	—	—	—	—
Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 3 Muscle pain (Mild)	13.2 Percentage of Participants Interval 7.4 to 21.2	5.8 Percentage of Participants Interval 2.2 to 12.2	—	—	—	—	—
Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 3 Muscle pain (Moderate)	5.7 Percentage of Participants Interval 2.1 to 11.9	8.7 Percentage of Participants Interval 4.1 to 15.9	—	—	—	—	—
Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 3 Muscle pain (Severe)	0 Percentage of Participants Interval 0.0 to 3.4	0 Percentage of Participants Interval 0.0 to 3.5	—	—	—	—	—

PRIMARY outcome

Timeframe: Day 1 (day of vaccination) through 1 Month post vaccination

Population: Safety analysis set included all participants who received a dose of GBS6 vaccine or placebo.

Outcome measures

Outcome measures
Measure	Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) n=40 Participants Nonpregnant participants were randomized to receive a primary of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) n=40 Participants Nonpregnant participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 1: Placebo (Nonpregnant) n=40 Participants Non pregnant participants were randomized to receive placebo (saline control) intramuscularly on Day 1.	Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) n=40 Participants Maternal participants were randomized to receive a single dose of 10 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg With AlPO4 (Maternal) n=40 Participants Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) n=40 Participants Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: Placebo (Maternal) n=120 Participants Maternal participants were randomized to receive placebo (saline control) intramuscularly on Day 1.
Percentage of Participants Reporting AEs Through 1 Month After Administration of Investigational Product: Maternal Participants Stage 2	27.5 Percentage of Participants Interval 14.6 to 43.9	40.0 Percentage of Participants Interval 24.9 to 56.7	22.5 Percentage of Participants Interval 10.8 to 38.5	22.5 Percentage of Participants Interval 10.8 to 38.5	30.0 Percentage of Participants Interval 16.6 to 46.5	30.0 Percentage of Participants Interval 16.6 to 46.7	27.5 Percentage of Participants Interval 19.7 to 36.7

PRIMARY outcome

Timeframe: Day 1 (day of vaccination) through 1 Month post vaccination

Population: Safety analysis set included all participants who received a dose of GBS6 vaccine or placebo.

Outcome measures

Outcome measures
Measure	Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) n=108 Participants Nonpregnant participants were randomized to receive a primary of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) n=108 Participants Nonpregnant participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 1: Placebo (Nonpregnant) Non pregnant participants were randomized to receive placebo (saline control) intramuscularly on Day 1.	Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) Maternal participants were randomized to receive a single dose of 10 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg With AlPO4 (Maternal) Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: Placebo (Maternal) Maternal participants were randomized to receive placebo (saline control) intramuscularly on Day 1.
Percentage of Participants Reporting AEs Through 1 Month After Administration of Investigational Product: Maternal Participants Stage 3	36.1 Percentage of Participants Interval 27.1 to 45.9	32.4 Percentage of Participants Interval 23.7 to 42.1	—	—	—	—	—

PRIMARY outcome

Timeframe: Day 1 (day of vaccination) through 12 Month post delivery

Population: Safety analysis set included all participants who received a dose of GBS6 vaccine or placebo.

Outcome measures

Outcome measures
Measure	Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) n=40 Participants Nonpregnant participants were randomized to receive a primary of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) n=40 Participants Nonpregnant participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 1: Placebo (Nonpregnant) n=40 Participants Non pregnant participants were randomized to receive placebo (saline control) intramuscularly on Day 1.	Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) n=40 Participants Maternal participants were randomized to receive a single dose of 10 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg With AlPO4 (Maternal) n=40 Participants Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) n=40 Participants Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: Placebo (Maternal) n=120 Participants Maternal participants were randomized to receive placebo (saline control) intramuscularly on Day 1.
Percentage of Participants With SAEs From Day 1 Through 12 Months Post-delivery: Maternal Participants Stage 2	17.5 Percentage of Participants Interval 7.3 to 32.8	45.0 Percentage of Participants Interval 29.3 to 61.5	22.5 Percentage of Participants Interval 0.8 to 38.5	27.5 Percentage of Participants Interval 14.6 to 43.9	20.0 Percentage of Participants Interval 9.1 to 35.6	35.0 Percentage of Participants Interval 20.6 to 51.7	25.0 Percentage of Participants Interval 17.5 to 33.7

PRIMARY outcome

Timeframe: Day 1 (day of vaccination) through 12 Month post delivery

Population: Safety analysis set included all participants who received a dose of GBS6 vaccine or placebo.

Outcome measures

Outcome measures
Measure	Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) n=108 Participants Nonpregnant participants were randomized to receive a primary of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) n=108 Participants Nonpregnant participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 1: Placebo (Nonpregnant) Non pregnant participants were randomized to receive placebo (saline control) intramuscularly on Day 1.	Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) Maternal participants were randomized to receive a single dose of 10 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg With AlPO4 (Maternal) Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: Placebo (Maternal) Maternal participants were randomized to receive placebo (saline control) intramuscularly on Day 1.
Percentage of Participants With SAEs From Day 1 Through 12 Months Post-delivery: Maternal Participants Stage 3	19.4 Percentage of Participants Interval 12.5 to 28.2	21.3 Percentage of Participants Interval 14.0 to 30.2	—	—	—	—	—

PRIMARY outcome

Timeframe: Day 1 (day of vaccination) through 12 Month post delivery

Population: Safety analysis set included all participants who received a dose of GBS6 vaccine or placebo.

Outcome measures

Outcome measures
Measure	Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) n=40 Participants Nonpregnant participants were randomized to receive a primary of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) n=40 Participants Nonpregnant participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 1: Placebo (Nonpregnant) n=40 Participants Non pregnant participants were randomized to receive placebo (saline control) intramuscularly on Day 1.	Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) n=40 Participants Maternal participants were randomized to receive a single dose of 10 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg With AlPO4 (Maternal) n=40 Participants Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) n=40 Participants Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: Placebo (Maternal) n=120 Participants Maternal participants were randomized to receive placebo (saline control) intramuscularly on Day 1.
Percentage of Participants With MAEs From Day 1 Through 12 Months Post-delivery: Maternal Participants Stage 2	30.0 Percentage of Participants Interval 16.6 to 46.5	45.0 Percentage of Participants Interval 29.3 to 61.5	30.0 Percentage of Participants Interval 16.6 to 46.5	27.5 Percentage of Participants Interval 14.6 to 43.9	25.0 Percentage of Participants Interval 12.7 to 41.2	32.5 Percentage of Participants Interval 18.6 to 49.1	42.5 Percentage of Participants Interval 33.5 to 51.9

PRIMARY outcome

Timeframe: Day 1 (day of vaccination) through 12 Month post delivery

Population: Safety analysis set included all participants who received a dose of GBS6 vaccine or placebo.

Outcome measures

Outcome measures
Measure	Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) n=108 Participants Nonpregnant participants were randomized to receive a primary of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) n=108 Participants Nonpregnant participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 1: Placebo (Nonpregnant) Non pregnant participants were randomized to receive placebo (saline control) intramuscularly on Day 1.	Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) Maternal participants were randomized to receive a single dose of 10 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg With AlPO4 (Maternal) Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: Placebo (Maternal) Maternal participants were randomized to receive placebo (saline control) intramuscularly on Day 1.
Percentage of Participants With MAEs From Day 1 Through 12 Months Post-delivery: Maternal Participants Stage 3	51.9 Percentage of Participants Interval 42.0 to 61.6	42.6 Percentage of Participants Interval 33.1 to 52.5	—	—	—	—	—

PRIMARY outcome

Timeframe: Day 1 (day of vaccination) through 12 Month post delivery

Population: Safety analysis set included all participants who received a dose of GBS6 vaccine or placebo.

Obstetric complications such as: prepartum period, intrapartum period and postpartum period were reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) n=40 Participants Nonpregnant participants were randomized to receive a primary of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) n=40 Participants Nonpregnant participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 1: Placebo (Nonpregnant) n=40 Participants Non pregnant participants were randomized to receive placebo (saline control) intramuscularly on Day 1.	Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) n=40 Participants Maternal participants were randomized to receive a single dose of 10 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg With AlPO4 (Maternal) n=40 Participants Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) n=40 Participants Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: Placebo (Maternal) n=120 Participants Maternal participants were randomized to receive placebo (saline control) intramuscularly on Day 1.
Percentage of Participants With Obstetric Complications From Visit 1 Through 12 Months Post-delivery: Maternal Participants Stage 2 Prepartum Period	5.0 Percentage of Participants Interval 0.6 to 16.9	12.5 Percentage of Participants Interval 4.2 to 26.8	5.0 Percentage of Participants Interval 0.6 to 16.9	10.0 Percentage of Participants Interval 2.8 to 23.7	5.0 Percentage of Participants Interval 0.6 to 16.9	10.0 Percentage of Participants Interval 2.8 to 23.7	11.7 Percentage of Participants Interval 6.5 to 18.8
Percentage of Participants With Obstetric Complications From Visit 1 Through 12 Months Post-delivery: Maternal Participants Stage 2 Intrapartum Period	10.0 Percentage of Participants Interval 2.8 to 23.7	30.0 Percentage of Participants Interval 16.6 to 46.5	10.0 Percentage of Participants Interval 2.8 to 23.7	15.0 Percentage of Participants Interval 5.7 to 29.8	10.0 Percentage of Participants Interval 2.8 to 23.7	20.0 Percentage of Participants Interval 9.1 to 35.6	11.7 Percentage of Participants Interval 6.5 to 18.8
Percentage of Participants With Obstetric Complications From Visit 1 Through 12 Months Post-delivery: Maternal Participants Stage 2 Postpartum Period	0 Percentage of Participants Interval 0.0 to 8.8	2.5 Percentage of Participants Interval 0.1 to 13.2	2.5 Percentage of Participants Interval 0.1 to 13.2	0 Percentage of Participants Interval 0.0 to 8.8	0 Percentage of Participants Interval 0.0 to 8.8	0 Percentage of Participants Interval 0.0 to 8.8	1.7 Percentage of Participants Interval 0.2 to 5.9

PRIMARY outcome

Timeframe: Day 1 (day of vaccination) through 12 Month post delivery

Population: Safety analysis set included all participants who received a dose of GBS6 vaccine or placebo.

Obstetric complications such as: prepartum period, intrapartum period and postpartum period were reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) n=108 Participants Nonpregnant participants were randomized to receive a primary of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) n=108 Participants Nonpregnant participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 1: Placebo (Nonpregnant) Non pregnant participants were randomized to receive placebo (saline control) intramuscularly on Day 1.	Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) Maternal participants were randomized to receive a single dose of 10 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg With AlPO4 (Maternal) Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: Placebo (Maternal) Maternal participants were randomized to receive placebo (saline control) intramuscularly on Day 1.
Percentage of Participants With Obstetric Complications From Day 1 Through 12 Months Post-delivery: Maternal Participants Stage 3 Prepartum Period	9.3 Percentage of Participants Interval 4.5 to 16.4	13.0 Percentage of Participants Interval 7.3 to 20.8	—	—	—	—	—
Percentage of Participants With Obstetric Complications From Day 1 Through 12 Months Post-delivery: Maternal Participants Stage 3 Intrapartum Period	13.9 Percentage of Participants Interval 8.0 to 21.9	13.0 Percentage of Participants Interval 7.3 to 20.8	—	—	—	—	—
Percentage of Participants With Obstetric Complications From Day 1 Through 12 Months Post-delivery: Maternal Participants Stage 3 Postpartum Period	2.8 Percentage of Participants Interval 0.6 to 7.9	1.9 Percentage of Participants Interval 0.2 to 6.5	—	—	—	—	—

PRIMARY outcome

Timeframe: At delivery

Population: Safety analysis set included all participants who received a dose of GBS6 vaccine or placebo.

Delivery Outcome included full term live delivery, premature live delivery, Stillbirth, induced/elective abortion and unknown. Mode of delivery included: vaginal delivery, Cesarean section: elective, semi-elective and emergency were reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) n=40 Participants Nonpregnant participants were randomized to receive a primary of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) n=40 Participants Nonpregnant participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 1: Placebo (Nonpregnant) n=40 Participants Non pregnant participants were randomized to receive placebo (saline control) intramuscularly on Day 1.	Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) n=40 Participants Maternal participants were randomized to receive a single dose of 10 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg With AlPO4 (Maternal) n=40 Participants Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) n=40 Participants Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: Placebo (Maternal) n=120 Participants Maternal participants were randomized to receive placebo (saline control) intramuscularly on Day 1.
Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 2 Full term live delivery	92.5 Percentage of Participants	90.0 Percentage of Participants	97.5 Percentage of Participants	100.0 Percentage of Participants	97.5 Percentage of Participants	97.5 Percentage of Participants	95.8 Percentage of Participants
Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 2 Premature live delivery	7.5 Percentage of Participants	7.5 Percentage of Participants	2.5 Percentage of Participants	0 Percentage of Participants	2.5 Percentage of Participants	2.5 Percentage of Participants	2.5 Percentage of Participants
Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 2 Stillbirth	0 Percentage of Participants	2.5 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 2 Induced/elective abortion	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 2 Delivery outcome-Unknown	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	1.7 Percentage of Participants
Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 2 Vaginal delivery	85.0 Percentage of Participants	60.0 Percentage of Participants	82.5 Percentage of Participants	67.5 Percentage of Participants	82.5 Percentage of Participants	70.0 Percentage of Participants	76.7 Percentage of Participants
Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 2 Cesarean section: elective	5.0 Percentage of Participants	12.5 Percentage of Participants	7.5 Percentage of Participants	5.0 Percentage of Participants	5.0 Percentage of Participants	10.0 Percentage of Participants	8.3 Percentage of Participants
Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 2 Cesarean section: semi-elective	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0.8 Percentage of Participants
Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 2 Cesarean section: emergency	10.0 Percentage of Participants	27.5 Percentage of Participants	10.0 Percentage of Participants	27.5 Percentage of Participants	12.5 Percentage of Participants	20.0 Percentage of Participants	12.5 Percentage of Participants
Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 2 Delivery mode-Unknown	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	1.7 Percentage of Participants

PRIMARY outcome

Timeframe: At delivery

Population: Safety analysis set included all participants who received a dose of GBS6 vaccine or placebo.

Outcome measures

Outcome measures
Measure	Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) n=108 Participants Nonpregnant participants were randomized to receive a primary of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) n=108 Participants Nonpregnant participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 1: Placebo (Nonpregnant) Non pregnant participants were randomized to receive placebo (saline control) intramuscularly on Day 1.	Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) Maternal participants were randomized to receive a single dose of 10 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg With AlPO4 (Maternal) Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: Placebo (Maternal) Maternal participants were randomized to receive placebo (saline control) intramuscularly on Day 1.
Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 3 Full term live delivery	88.0 Percentage of Participants	91.7 Percentage of Participants	—	—	—	—	—
Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 3 Premature live delivery	7.4 Percentage of Participants	5.6 Percentage of Participants	—	—	—	—	—
Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 3 Stillbirth	0.9 Percentage of Participants	0 Percentage of Participants	—	—	—	—	—
Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 3 Induced/elective abortion	0 Percentage of Participants	0 Percentage of Participants	—	—	—	—	—
Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 3 Delivery outcome-Unknown	3.7 Percentage of Participants	2.7 Percentage of Participants	—	—	—	—	—
Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 3 Vaginal delivery	72.2 Percentage of Participants	75.9 Percentage of Participants	—	—	—	—	—
Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 3 Cesarean section: elective	12.0 Percentage of Participants	9.3 Percentage of Participants	—	—	—	—	—
Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 3 Cesarean section: semi-elective	1.9 Percentage of Participants	0 Percentage of Participants	—	—	—	—	—
Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 3 Cesarean section: emergency	10.2 Percentage of Participants	12.0 Percentage of Participants	—	—	—	—	—
Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 3 Delivery mode-Unknown	3.7 Percentage of Participants	2.8 Percentage of Participants	—	—	—	—	—

PRIMARY outcome

Timeframe: At Birth

Population: Safety analysis set included all participants whose mother received a dose of GBS6 vaccine or placebo.

Gestational age of participants at birth in weeks included: greater than or equal to (\>=)24 weeks to less than (\<) 28 weeks, \>=28 weeks to \<34 weeks, \>=34 weeks to \<37 weeks, \>=37 weeks to \<42 weeks, \>=42 weeks.

Outcome measures

Outcome measures
Measure	Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) n=40 Participants Nonpregnant participants were randomized to receive a primary of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) n=39 Participants Nonpregnant participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 1: Placebo (Nonpregnant) n=40 Participants Non pregnant participants were randomized to receive placebo (saline control) intramuscularly on Day 1.	Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) n=40 Participants Maternal participants were randomized to receive a single dose of 10 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg With AlPO4 (Maternal) n=40 Participants Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) n=40 Participants Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: Placebo (Maternal) n=118 Participants Maternal participants were randomized to receive placebo (saline control) intramuscularly on Day 1.
Percentage of Participants With Gestational Age at Birth: Infant Participants Stage 2 >=42 weeks	5.0 Percentage of Participants	7.7 Percentage of Participants	0 Percentage of Participants	7.5 Percentage of Participants	2.5 Percentage of Participants	2.5 Percentage of Participants	3.4 Percentage of Participants
Percentage of Participants With Gestational Age at Birth: Infant Participants Stage 2 >=24 weeks to <28 weeks	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With Gestational Age at Birth: Infant Participants Stage 2 >=28 weeks to <34 weeks	2.5 Percentage of Participants	2.6 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With Gestational Age at Birth: Infant Participants Stage 2 >=34 weeks to <37 weeks	5.0 Percentage of Participants	5.1 Percentage of Participants	2.5 Percentage of Participants	0 Percentage of Participants	2.5 Percentage of Participants	2.5 Percentage of Participants	1.7 Percentage of Participants
Percentage of Participants With Gestational Age at Birth: Infant Participants Stage 2 >=37 weeks to <42 weeks	87.5 Percentage of Participants	84.6 Percentage of Participants	97.5 Percentage of Participants	92.5 Percentage of Participants	95.0 Percentage of Participants	95.0 Percentage of Participants	94.9 Percentage of Participants

PRIMARY outcome

Timeframe: At 1 minute of Birth

Population: Safety analysis set included all participants whose mother received a dose of GBS6 vaccine or placebo. Here, "Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.

APGAR is a scoring system that evaluates Activity, Pulse, Grimace, Appearance, and Respiration. Each category is given a score of 0-2 points (with 0 being absent and 2 being normal), the points are then combined for a total score that ranges from 0-10. Scores 7 and above are generally normal, 4 to 6 are fairly low, and 2 and below are considered critically low. APGAR score at 1 minute were reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) n=40 Participants Nonpregnant participants were randomized to receive a primary of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) n=38 Participants Nonpregnant participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 1: Placebo (Nonpregnant) n=40 Participants Non pregnant participants were randomized to receive placebo (saline control) intramuscularly on Day 1.	Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) n=40 Participants Maternal participants were randomized to receive a single dose of 10 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg With AlPO4 (Maternal) n=40 Participants Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) n=40 Participants Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: Placebo (Maternal) n=113 Participants Maternal participants were randomized to receive placebo (saline control) intramuscularly on Day 1.
Appearance, Pulse, Grimace, Activity, and Respiration (APGAR) Score at 1 Minute: Infant Participants Stage 2	9.0 Unit on a scale Interval 8.0 to 9.0	9.0 Unit on a scale Interval 6.0 to 9.0	9.0 Unit on a scale Interval 8.0 to 9.0	9.0 Unit on a scale Interval 7.0 to 9.0	9.0 Unit on a scale Interval 3.0 to 9.0	9.0 Unit on a scale Interval 5.0 to 9.0	9.0 Unit on a scale Interval 1.0 to 9.0

PRIMARY outcome

Timeframe: At 5 minutes of Birth

Population: Safety analysis set included all participants whose mother received a dose of GBS6 vaccine or placebo.

Outcome measures

Outcome measures
Measure	Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) n=40 Participants Nonpregnant participants were randomized to receive a primary of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) n=39 Participants Nonpregnant participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 1: Placebo (Nonpregnant) n=40 Participants Non pregnant participants were randomized to receive placebo (saline control) intramuscularly on Day 1.	Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) n=40 Participants Maternal participants were randomized to receive a single dose of 10 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg With AlPO4 (Maternal) n=40 Participants Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) n=40 Participants Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: Placebo (Maternal) n=118 Participants Maternal participants were randomized to receive placebo (saline control) intramuscularly on Day 1.
Appearance, Pulse, Grimace, Activity, and Respiration (APGAR) Score at 5 Minutes: Infant Participants Stage 2	10.0 Unit on a scale Interval 8.0 to 10.0	10.0 Unit on a scale Interval 8.0 to 10.0	10.0 Unit on a scale Interval 9.0 to 10.0	10.0 Unit on a scale Interval 9.0 to 10.0	10.0 Unit on a scale Interval 7.0 to 10.0	10.0 Unit on a scale Interval 5.0 to 10.0	10.0 Unit on a scale Interval 4.0 to 10.0

PRIMARY outcome

Timeframe: At Birth

Population: Safety analysis set included all participants whose mother received a dose of GBS6 vaccine or placebo.

The Ballard score is a commonly used technique of gestational age assessment. It assists healthcare providers in determining if an infant is premature, on time, or post-term based on physical traits. This scoring allows for the estimation of age in the range of 26 weeks to 44 weeks Participants according to age determined by Ballard score: at \<37 weeks 0 days, \>=37 weeks to \<42 weeks, \>=42 weeks were reported in this outcome measure. Ballard score was not conducted routinely/mandatory.

Outcome measures

Outcome measures
Measure	Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) n=40 Participants Nonpregnant participants were randomized to receive a primary of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) n=39 Participants Nonpregnant participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 1: Placebo (Nonpregnant) n=40 Participants Non pregnant participants were randomized to receive placebo (saline control) intramuscularly on Day 1.	Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) n=40 Participants Maternal participants were randomized to receive a single dose of 10 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg With AlPO4 (Maternal) n=40 Participants Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) n=40 Participants Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: Placebo (Maternal) n=118 Participants Maternal participants were randomized to receive placebo (saline control) intramuscularly on Day 1.
Number of Participants According to Age Determined by Ballard Score: Infant Participants Stage 2 <37 weeks 0 days	1 Participants Interval 8.0 to 10.0	2 Participants Interval 8.0 to 10.0	1 Participants Interval 9.0 to 10.0	1 Participants Interval 9.0 to 10.0	2 Participants Interval 7.0 to 10.0	2 Participants Interval 5.0 to 10.0	4 Participants Interval 4.0 to 10.0
Number of Participants According to Age Determined by Ballard Score: Infant Participants Stage 2 >=37 weeks to <42 weeks	6 Participants	3 Participants	7 Participants	4 Participants	3 Participants	4 Participants	18 Participants
Number of Participants According to Age Determined by Ballard Score: Infant Participants Stage 2 >=42 weeks	1 Participants	1 Participants	1 Participants	1 Participants	4 Participants	0 Participants	2 Participants
Number of Participants According to Age Determined by Ballard Score: Infant Participants Stage 2 Not reported	32 Participants	33 Participants	31 Participants	34 Participants	31 Participants	34 Participants	94 Participants

PRIMARY outcome

Timeframe: At Birth

Population: Safety analysis set included all participants whose mother received a dose of GBS6 vaccine or placebo.

Participants with newborn assessment at birth included: normal, congenital malformation/anomaly, other neonatal problem were reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) n=40 Participants Nonpregnant participants were randomized to receive a primary of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) n=39 Participants Nonpregnant participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 1: Placebo (Nonpregnant) n=40 Participants Non pregnant participants were randomized to receive placebo (saline control) intramuscularly on Day 1.	Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) n=40 Participants Maternal participants were randomized to receive a single dose of 10 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg With AlPO4 (Maternal) n=40 Participants Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) n=40 Participants Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: Placebo (Maternal) n=118 Participants Maternal participants were randomized to receive placebo (saline control) intramuscularly on Day 1.
Number of Participants With Newborn Assessment at Birth: Infant Participants Stage 2 Normal	34 Participants Interval 8.0 to 10.0	30 Participants Interval 8.0 to 10.0	38 Participants Interval 9.0 to 10.0	38 Participants Interval 9.0 to 10.0	34 Participants Interval 7.0 to 10.0	35 Participants Interval 5.0 to 10.0	89 Participants Interval 4.0 to 10.0
Number of Participants With Newborn Assessment at Birth: Infant Participants Stage 2 Congenital malformation/anomaly	7 Participants	8 Participants	2 Participants	2 Participants	5 Participants	6 Participants	26 Participants
Number of Participants With Newborn Assessment at Birth: Infant Participants Stage 2 Other neonatal problem	3 Participants	4 Participants	2 Participants	2 Participants	2 Participants	4 Participants	5 Participants

PRIMARY outcome

Timeframe: At Birth

Population: Safety analysis set included all participants whose mother received a dose of GBS6 vaccine or placebo.

Participants according to vital status as: live or neonatal death were reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) n=40 Participants Nonpregnant participants were randomized to receive a primary of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) n=39 Participants Nonpregnant participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 1: Placebo (Nonpregnant) n=40 Participants Non pregnant participants were randomized to receive placebo (saline control) intramuscularly on Day 1.	Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) n=40 Participants Maternal participants were randomized to receive a single dose of 10 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg With AlPO4 (Maternal) n=40 Participants Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) n=40 Participants Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: Placebo (Maternal) n=118 Participants Maternal participants were randomized to receive placebo (saline control) intramuscularly on Day 1.
Number of Participants With Vital Status: Infant Participants Stage 2 Live	40 Participants Interval 8.0 to 10.0	38 Participants Interval 8.0 to 10.0	40 Participants Interval 9.0 to 10.0	40 Participants Interval 9.0 to 10.0	40 Participants Interval 7.0 to 10.0	40 Participants Interval 5.0 to 10.0	117 Participants Interval 4.0 to 10.0
Number of Participants With Vital Status: Infant Participants Stage 2 Neonatal death	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants

PRIMARY outcome

Timeframe: At 1 minute of Birth

Population: Safety analysis set included all participants whose mother received a dose of GBS6 vaccine or placebo.

Outcome measures

Outcome measures
Measure	Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) n=104 Participants Nonpregnant participants were randomized to receive a primary of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) n=105 Participants Nonpregnant participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 1: Placebo (Nonpregnant) Non pregnant participants were randomized to receive placebo (saline control) intramuscularly on Day 1.	Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) Maternal participants were randomized to receive a single dose of 10 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg With AlPO4 (Maternal) Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: Placebo (Maternal) Maternal participants were randomized to receive placebo (saline control) intramuscularly on Day 1.
Number of Participants With Gestational Age of Participants at Birth: Infant Participants Stage 3 >=24 weeks to <28 weeks	0 Participants	0 Participants	—	—	—	—	—
Number of Participants With Gestational Age of Participants at Birth: Infant Participants Stage 3 >=28 weeks to <34 weeks	1 Participants	2 Participants	—	—	—	—	—
Number of Participants With Gestational Age of Participants at Birth: Infant Participants Stage 3 >=34 weeks to <37 weeks	7 Participants	4 Participants	—	—	—	—	—
Number of Participants With Gestational Age of Participants at Birth: Infant Participants Stage 3 >=37 weeks to <42 weeks	94 Participants	94 Participants	—	—	—	—	—
Number of Participants With Gestational Age of Participants at Birth: Infant Participants Stage 3 >=42 weeks	1 Participants	4 Participants	—	—	—	—	—
Number of Participants With Gestational Age of Participants at Birth: Infant Participants Stage 3 Unknown	1 Participants	1 Participants	—	—	—	—	—

PRIMARY outcome

Timeframe: At 1 minute of Birth

Population: Safety analysis set included all participants whose mother received a dose of GBS6 vaccine or placebo.

APGAR is a scoring system that evaluates Activity, Pulse, Grimace, Appearance, and Respiration. Each category is given a score of 0-2 points (with 0 being absent and 2 being normal), the points are then combined for a total score that ranges from 0-10. Scores 7 and above are generally normal, 4 to 6 are fairly low, and 2 and below are considered critically low. Appearance, pulse, grimace, activity, and respiration (APGAR) score at 1 minute were reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) n=104 Participants Nonpregnant participants were randomized to receive a primary of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) n=105 Participants Nonpregnant participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 1: Placebo (Nonpregnant) Non pregnant participants were randomized to receive placebo (saline control) intramuscularly on Day 1.	Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) Maternal participants were randomized to receive a single dose of 10 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg With AlPO4 (Maternal) Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: Placebo (Maternal) Maternal participants were randomized to receive placebo (saline control) intramuscularly on Day 1.
Appearance, Pulse, Grimace, Activity, and Respiration (APGAR) Score at 1 Minute: Infant Participants Stage 3	9.0 Unit on a scale Interval 2.0 to 10.0	9.0 Unit on a scale Interval 1.0 to 9.0	—	—	—	—	—

PRIMARY outcome

Timeframe: At 5 minutes of Birth

Population: Safety analysis set included all participants whose mother received a dose of GBS6 vaccine or placebo.

APGAR is a scoring system that evaluates Activity, Pulse, Grimace, Appearance, and Respiration. Each category is given a score of 0-2 points (with 0 being absent and 2 being normal), the points are then combined for a total score that ranges from 0-10. Scores 7 and above are generally normal, 4 to 6 are fairly low, and 2 and below are considered critically low. Appearance, pulse, grimace, activity, and respiration (APGAR) score at 5 minute were reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) n=104 Participants Nonpregnant participants were randomized to receive a primary of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) n=105 Participants Nonpregnant participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 1: Placebo (Nonpregnant) Non pregnant participants were randomized to receive placebo (saline control) intramuscularly on Day 1.	Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) Maternal participants were randomized to receive a single dose of 10 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg With AlPO4 (Maternal) Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: Placebo (Maternal) Maternal participants were randomized to receive placebo (saline control) intramuscularly on Day 1.
APGAR Score at 5 Minutes: Infant Participants Stage 3	10.0 Unit on a scale Interval 7.0 to 10.0	10.0 Unit on a scale Interval 4.0 to 10.0	—	—	—	—	—

PRIMARY outcome

Timeframe: At Birth

Population: Safety analysis set included all participants whose mother received a dose of GBS6 vaccine or placebo.

Outcome measures

Outcome measures
Measure	Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) n=104 Participants Nonpregnant participants were randomized to receive a primary of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) n=105 Participants Nonpregnant participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 1: Placebo (Nonpregnant) Non pregnant participants were randomized to receive placebo (saline control) intramuscularly on Day 1.	Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) Maternal participants were randomized to receive a single dose of 10 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg With AlPO4 (Maternal) Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: Placebo (Maternal) Maternal participants were randomized to receive placebo (saline control) intramuscularly on Day 1.
Number of Participants According to Age Determined by Ballard Score: Infant Participants Stage 3 <37 weeks 0 days	4 Participants	4 Participants	—	—	—	—	—
Number of Participants According to Age Determined by Ballard Score: Infant Participants Stage 3 >=37 weeks to <42 weeks	30 Participants	37 Participants	—	—	—	—	—
Number of Participants According to Age Determined by Ballard Score: Infant Participants Stage 3 >=42 weeks	5 Participants	4 Participants	—	—	—	—	—
Number of Participants According to Age Determined by Ballard Score: Infant Participants Stage 3 Not reported	65 Participants	60 Participants	—	—	—	—	—

PRIMARY outcome

Timeframe: At 5 minutes of Birth

Population: Safety analysis set included all participants whose mother received a dose of GBS6 vaccine or placebo.

Participants with newborn assessment at birth included: normal, congenital malformation/anomaly, other neonatal problem were reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) n=104 Participants Nonpregnant participants were randomized to receive a primary of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) n=105 Participants Nonpregnant participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 1: Placebo (Nonpregnant) Non pregnant participants were randomized to receive placebo (saline control) intramuscularly on Day 1.	Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) Maternal participants were randomized to receive a single dose of 10 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg With AlPO4 (Maternal) Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: Placebo (Maternal) Maternal participants were randomized to receive placebo (saline control) intramuscularly on Day 1.
Number of Participants With Newborn Assessment at Birth: Infant Participants Stage 3 Normal	82 Participants	79 Participants	—	—	—	—	—
Number of Participants With Newborn Assessment at Birth: Infant Participants Stage 3 Congenital malformation/anomaly	15 Participants	16 Participants	—	—	—	—	—
Number of Participants With Newborn Assessment at Birth: Infant Participants Stage 3 Other neonatal problem	12 Participants	15 Participants	—	—	—	—	—

PRIMARY outcome

Timeframe: At Birth

Population: Safety analysis set included all participants whose mother received a dose of GBS6 vaccine or placebo.

Participants according to vital status as: live or neonatal death were reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) n=104 Participants Nonpregnant participants were randomized to receive a primary of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) n=105 Participants Nonpregnant participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 1: Placebo (Nonpregnant) Non pregnant participants were randomized to receive placebo (saline control) intramuscularly on Day 1.	Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) Maternal participants were randomized to receive a single dose of 10 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg With AlPO4 (Maternal) Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: Placebo (Maternal) Maternal participants were randomized to receive placebo (saline control) intramuscularly on Day 1.
Number of Participants With Vital Status: Infant Participants Stage 3 Live	103 Participants	104 Participants	—	—	—	—	—
Number of Participants With Vital Status: Infant Participants Stage 3 Neonatal death	1 Participants	1 Participants	—	—	—	—	—

PRIMARY outcome

Timeframe: From Birth to 6 Weeks

Population: Safety analysis set included all participants whose mother received a dose of GBS6 vaccine or placebo.

Outcome measures

Outcome measures
Measure	Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) n=40 Participants Nonpregnant participants were randomized to receive a primary of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) n=39 Participants Nonpregnant participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 1: Placebo (Nonpregnant) n=40 Participants Non pregnant participants were randomized to receive placebo (saline control) intramuscularly on Day 1.	Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) n=40 Participants Maternal participants were randomized to receive a single dose of 10 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg With AlPO4 (Maternal) n=40 Participants Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) n=40 Participants Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: Placebo (Maternal) n=118 Participants Maternal participants were randomized to receive placebo (saline control) intramuscularly on Day 1.
Number of Participants With AEs From Birth to 6 Weeks of Age: Infant Participants Stage 2	26 Participants Interval 8.0 to 10.0	21 Participants Interval 8.0 to 10.0	25 Participants Interval 9.0 to 10.0	21 Participants Interval 9.0 to 10.0	19 Participants Interval 7.0 to 10.0	18 Participants Interval 5.0 to 10.0	68 Participants Interval 4.0 to 10.0

PRIMARY outcome

Timeframe: From Birth to 6 Weeks

Population: Safety analysis set included all participants whose mother received a dose of GBS6 vaccine or placebo.

Outcome measures

Outcome measures
Measure	Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) n=104 Participants Nonpregnant participants were randomized to receive a primary of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) n=105 Participants Nonpregnant participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 1: Placebo (Nonpregnant) Non pregnant participants were randomized to receive placebo (saline control) intramuscularly on Day 1.	Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) Maternal participants were randomized to receive a single dose of 10 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg With AlPO4 (Maternal) Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: Placebo (Maternal) Maternal participants were randomized to receive placebo (saline control) intramuscularly on Day 1.
Numberof Participants With AEs From Birth to 6 Weeks of Age: Infant Participants Stage 3	65 Participants	64 Participants	—	—	—	—	—

PRIMARY outcome

Timeframe: From Birth to 12 Months

Population: Safety analysis set included all participants whose mothers received a dose of GBS6 vaccine or placebo.

An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. A SAE was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); congenital anomaly/birth defect; or that was considered as an important medical event.

Outcome measures

Outcome measures
Measure	Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) n=40 Participants Nonpregnant participants were randomized to receive a primary of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) n=39 Participants Nonpregnant participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 1: Placebo (Nonpregnant) n=40 Participants Non pregnant participants were randomized to receive placebo (saline control) intramuscularly on Day 1.	Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) n=40 Participants Maternal participants were randomized to receive a single dose of 10 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg With AlPO4 (Maternal) n=40 Participants Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) n=40 Participants Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: Placebo (Maternal) n=118 Participants Maternal participants were randomized to receive placebo (saline control) intramuscularly on Day 1.
Number of Participants With SAEs From Birth to 12 Months of Age: Infant Participants Stage 2	17 Participants Interval 8.0 to 10.0	19 Participants Interval 8.0 to 10.0	15 Participants Interval 9.0 to 10.0	12 Participants Interval 9.0 to 10.0	19 Participants Interval 7.0 to 10.0	14 Participants Interval 5.0 to 10.0	60 Participants Interval 4.0 to 10.0

PRIMARY outcome

Timeframe: From Birth to 12 Months

Population: Safety analysis set included all participants whose mothers received a dose of GBS6 vaccine or placebo.

An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. A SAE was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); congenital anomaly/birth defect; or that was considered as an important medical event.

Outcome measures

Outcome measures
Measure	Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) n=104 Participants Nonpregnant participants were randomized to receive a primary of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) n=105 Participants Nonpregnant participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 1: Placebo (Nonpregnant) Non pregnant participants were randomized to receive placebo (saline control) intramuscularly on Day 1.	Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) Maternal participants were randomized to receive a single dose of 10 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg With AlPO4 (Maternal) Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: Placebo (Maternal) Maternal participants were randomized to receive placebo (saline control) intramuscularly on Day 1.
Number of Participants With SAEs From Birth to 12 Months of Age: Infant Participants Stage 3	45 Participants	46 Participants	—	—	—	—	—

PRIMARY outcome

Timeframe: From Birth to 12 Months

Population: Safety analysis set included all participants whose mothers received a dose of GBS6 vaccine or placebo.

Outcome measures

Outcome measures
Measure	Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) n=40 Participants Nonpregnant participants were randomized to receive a primary of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) n=39 Participants Nonpregnant participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 1: Placebo (Nonpregnant) n=40 Participants Non pregnant participants were randomized to receive placebo (saline control) intramuscularly on Day 1.	Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) n=40 Participants Maternal participants were randomized to receive a single dose of 10 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg With AlPO4 (Maternal) n=40 Participants Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) n=40 Participants Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: Placebo (Maternal) n=118 Participants Maternal participants were randomized to receive placebo (saline control) intramuscularly on Day 1.
Number of Participants With MAEs From Birth to 12 Months of Age: Infant Participants Stage 2	22 Participants Interval 8.0 to 10.0	14 Participants Interval 8.0 to 10.0	19 Participants Interval 9.0 to 10.0	21 Participants Interval 9.0 to 10.0	18 Participants Interval 7.0 to 10.0	18 Participants Interval 5.0 to 10.0	58 Participants Interval 4.0 to 10.0

PRIMARY outcome

Timeframe: From Birth to 12 Months

Population: Safety analysis set included all participants who received a dose of GBS6 vaccine or placebo.

Outcome measures

Outcome measures
Measure	Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) n=104 Participants Nonpregnant participants were randomized to receive a primary of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) n=105 Participants Nonpregnant participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 1: Placebo (Nonpregnant) Non pregnant participants were randomized to receive placebo (saline control) intramuscularly on Day 1.	Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) Maternal participants were randomized to receive a single dose of 10 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg With AlPO4 (Maternal) Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: Placebo (Maternal) Maternal participants were randomized to receive placebo (saline control) intramuscularly on Day 1.
Number of Participants With MAEs From Birth to 12 Months of Age: Infant Participants Stage 3	65 Participants	66 Participants	—	—	—	—	—

PRIMARY outcome

Timeframe: From Birth to 12 Months

Population: Safety analysis set included all participants who received a dose of GBS6 vaccine or placebo.

An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. AEs of special interest included: major congenital anomalies, developmental delay and suspected or confirmed GBS infection.

Outcome measures

Outcome measures
Measure	Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) n=40 Participants Nonpregnant participants were randomized to receive a primary of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) n=39 Participants Nonpregnant participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 1: Placebo (Nonpregnant) n=40 Participants Non pregnant participants were randomized to receive placebo (saline control) intramuscularly on Day 1.	Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) n=40 Participants Maternal participants were randomized to receive a single dose of 10 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg With AlPO4 (Maternal) n=40 Participants Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) n=40 Participants Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: Placebo (Maternal) n=118 Participants Maternal participants were randomized to receive placebo (saline control) intramuscularly on Day 1.
Percentage of Participants With Adverse Events of Special Interest From Birth to 12 Months of Age: Infant Participants Stage 2 Major congenital anomalies	0 Participants of Participants Interval 0.0 to 8.8	2.6 Participants of Participants Interval 0.1 to 13.5	2.5 Participants of Participants Interval 0.1 to 13.2	0 Participants of Participants Interval 0.0 to 8.8	0 Participants of Participants Interval 0.0 to 8.8	0 Participants of Participants Interval 0.0 to 8.8	1.7 Participants of Participants Interval 0.2 to 6.0
Percentage of Participants With Adverse Events of Special Interest From Birth to 12 Months of Age: Infant Participants Stage 2 Developmental delay	0 Participants of Participants Interval 0.0 to 8.8	2.6 Participants of Participants Interval 0.1 to 13.5	0 Participants of Participants Interval 0.0 to 8.8	0 Participants of Participants Interval 0.0 to 8.8	2.5 Participants of Participants Interval 0.1 to 13.2	0 Participants of Participants Interval 0.0 to 8.8	0.8 Participants of Participants Interval 0.0 to 4.6
Percentage of Participants With Adverse Events of Special Interest From Birth to 12 Months of Age: Infant Participants Stage 2 Suspected or confirmed GBS infection	0 Participants of Participants Interval 0.0 to 8.8	0 Participants of Participants Interval 0.0 to 9.0	0 Participants of Participants Interval 0.0 to 8.8	0 Participants of Participants Interval 0.0 to 8.8	0 Participants of Participants Interval 0.0 to 8.8	0 Participants of Participants Interval 0.0 to 8.8	0 Participants of Participants Interval 0.0 to 3.1

PRIMARY outcome

Timeframe: From Birth to 12 Months

Population: Safety analysis set included all participants who received a dose of GBS6 vaccine or placebo.

An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. AEs of special interest included: major congenital anomalies, developmental delay and suspected or confirmed GBS infection.

Outcome measures

Outcome measures
Measure	Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) n=104 Participants Nonpregnant participants were randomized to receive a primary of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) n=105 Participants Nonpregnant participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 1: Placebo (Nonpregnant) Non pregnant participants were randomized to receive placebo (saline control) intramuscularly on Day 1.	Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) Maternal participants were randomized to receive a single dose of 10 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg With AlPO4 (Maternal) Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: Placebo (Maternal) Maternal participants were randomized to receive placebo (saline control) intramuscularly on Day 1.
Percentage of Participants With Adverse Events of Special Interest From Birth to 12 Months of Age: Infant Participants Stage 3 Major congenital anomalies	0 Percentage of Participants Interval 0.0 to 3.5	0 Percentage of Participants Interval 0.0 to 3.5	—	—	—	—	—
Percentage of Participants With Adverse Events of Special Interest From Birth to 12 Months of Age: Infant Participants Stage 3 Developmental delay	1.0 Percentage of Participants Interval 0.0 to 5.2	0 Percentage of Participants Interval 0.0 to 3.5	—	—	—	—	—
Percentage of Participants With Adverse Events of Special Interest From Birth to 12 Months of Age: Infant Participants Stage 3 Suspected or confirmed GBS infection	0 Percentage of Participants Interval 0.0 to 3.5	0 Percentage of Participants Interval 0.0 to 3.5	—	—	—	—	—

SECONDARY outcome

Timeframe: At 1 Month After primary Dose

Population: Evaluable immunogenicity population.

Serotypes used for evaluation were: Ia, Ib, II, III, IV, and V.

Outcome measures

Outcome measures
Measure	Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) n=22 Participants Nonpregnant participants were randomized to receive a primary of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) n=22 Participants Nonpregnant participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 1: Placebo (Nonpregnant) n=22 Participants Non pregnant participants were randomized to receive placebo (saline control) intramuscularly on Day 1.	Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) Maternal participants were randomized to receive a single dose of 10 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg With AlPO4 (Maternal) Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: Placebo (Maternal) Maternal participants were randomized to receive placebo (saline control) intramuscularly on Day 1.
Geometric Mean Concentration (GMCs) of Group B Streptococcus (GBS) Serotype-Specific Immunoglobulin G (IgG) at 1 Month After Primary Dose: Non-Pregnant Women Stage 1 Ia	64.729 microgram per milliliter Interval 19.893 to 210.612	25.781 microgram per milliliter Interval 8.04 to 82.661	0.152 microgram per milliliter Interval 0.029 to 0.807	—	—	—	—
Geometric Mean Concentration (GMCs) of Group B Streptococcus (GBS) Serotype-Specific Immunoglobulin G (IgG) at 1 Month After Primary Dose: Non-Pregnant Women Stage 1 Ib	4.986 microgram per milliliter Interval 1.639 to 15.165	5.546 microgram per milliliter Interval 1.497 to 20.549	0.019 microgram per milliliter Interval 0.009 to 0.039	—	—	—	—
Geometric Mean Concentration (GMCs) of Group B Streptococcus (GBS) Serotype-Specific Immunoglobulin G (IgG) at 1 Month After Primary Dose: Non-Pregnant Women Stage 1 II	23.359 microgram per milliliter Interval 10.941 to 49.87	37.920 microgram per milliliter Interval 14.374 to 100.033	0.179 microgram per milliliter Interval 0.087 to 0.365	—	—	—	—
Geometric Mean Concentration (GMCs) of Group B Streptococcus (GBS) Serotype-Specific Immunoglobulin G (IgG) at 1 Month After Primary Dose: Non-Pregnant Women Stage 1 III	22.622 microgram per milliliter Interval 8.569 to 59.725	19.065 microgram per milliliter Interval 8.43 to 43.116	0.068 microgram per milliliter Interval 0.022 to 0.213	—	—	—	—
Geometric Mean Concentration (GMCs) of Group B Streptococcus (GBS) Serotype-Specific Immunoglobulin G (IgG) at 1 Month After Primary Dose: Non-Pregnant Women Stage 1 IV	5.748 microgram per milliliter Interval 2.784 to 11.864	2.564 microgram per milliliter Interval 1.292 to 5.091	0.041 microgram per milliliter Interval 0.016 to 0.104	—	—	—	—
Geometric Mean Concentration (GMCs) of Group B Streptococcus (GBS) Serotype-Specific Immunoglobulin G (IgG) at 1 Month After Primary Dose: Non-Pregnant Women Stage 1 V	0.599 microgram per milliliter Interval 0.22 to 1.631	0.420 microgram per milliliter Interval 0.105 to 1.676	0.058 microgram per milliliter Interval 0.02 to 0.168	—	—	—	—

SECONDARY outcome

Timeframe: Before (immediately before booster vaccination) and at 1, 3 and 6 Months After vaccination as Booster Dose

Population: Evaluable immunogenicity population. Here, "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

Serotypes used for evaluation were: Ia, Ib, II, III, IV, and V.

Outcome measures

Outcome measures
Measure	Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) n=11 Participants Nonpregnant participants were randomized to receive a primary of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) n=7 Participants Nonpregnant participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 1: Placebo (Nonpregnant) n=7 Participants Non pregnant participants were randomized to receive placebo (saline control) intramuscularly on Day 1.	Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) Maternal participants were randomized to receive a single dose of 10 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg With AlPO4 (Maternal) Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: Placebo (Maternal) Maternal participants were randomized to receive placebo (saline control) intramuscularly on Day 1.
GMCs of GBS Serotype-specific IgG Before and 1 Month, 3 Months, and 6 Months After a Booster Dose: Non Pregnant Women Stage 1 Ia (Before)	21.088 microgram per milliliter Interval 5.663 to 78.52	3.230 microgram per milliliter Interval 0.164 to 63.426	0.812 microgram per milliliter Interval 0.026 to 25.244	—	—	—	—
GMCs of GBS Serotype-specific IgG Before and 1 Month, 3 Months, and 6 Months After a Booster Dose: Non Pregnant Women Stage 1 Ia (Month 1)	86.661 microgram per milliliter Interval 47.789 to 157.153	48.241 microgram per milliliter Interval 15.58 to 149.375	68.222 microgram per milliliter Interval 3.526 to 1319.87	—	—	—	—
GMCs of GBS Serotype-specific IgG Before and 1 Month, 3 Months, and 6 Months After a Booster Dose: Non Pregnant Women Stage 1 Ia (Month 3)	60.200 microgram per milliliter Interval 28.513 to 127.102	27.000 microgram per milliliter Interval 6.37 to 114.442	49.958 microgram per milliliter Interval 3.463 to 720.799	—	—	—	—
GMCs of GBS Serotype-specific IgG Before and 1 Month, 3 Months, and 6 Months After a Booster Dose: Non Pregnant Women Stage 1 Ia (Month 6)	51.631 microgram per milliliter Interval 21.557 to 123.66	18.936 microgram per milliliter Interval 4.154 to 86.321	23.140 microgram per milliliter Interval 2.552 to 209.826	—	—	—	—
GMCs of GBS Serotype-specific IgG Before and 1 Month, 3 Months, and 6 Months After a Booster Dose: Non Pregnant Women Stage 1 Ib (Before)	1.643 microgram per milliliter Interval 0.457 to 5.914	0.215 microgram per milliliter Interval 0.012 to 3.749	0.057 microgram per milliliter Interval 0.014 to 0.222	—	—	—	—
GMCs of GBS Serotype-specific IgG Before and 1 Month, 3 Months, and 6 Months After a Booster Dose: Non Pregnant Women Stage 1 Ib (Month 1)	29.416 microgram per milliliter Interval 17.765 to 48.706	11.171 microgram per milliliter Interval 2.526 to 49.402	6.176 microgram per milliliter Interval 0.928 to 41.11	—	—	—	—
GMCs of GBS Serotype-specific IgG Before and 1 Month, 3 Months, and 6 Months After a Booster Dose: Non Pregnant Women Stage 1 Ib (Month 3)	16.062 microgram per milliliter Interval 8.198 to 31.47	6.134 microgram per milliliter Interval 1.183 to 31.813	3.479 microgram per milliliter Interval 0.666 to 18.173	—	—	—	—
GMCs of GBS Serotype-specific IgG Before and 1 Month, 3 Months, and 6 Months After a Booster Dose: Non Pregnant Women Stage 1 Ib (Month 6)	11.053 microgram per milliliter Interval 4.697 to 26.01	4.033 microgram per milliliter Interval 0.753 to 21.588	2.304 microgram per milliliter Interval 0.446 to 11.896	—	—	—	—
GMCs of GBS Serotype-specific IgG Before and 1 Month, 3 Months, and 6 Months After a Booster Dose: Non Pregnant Women Stage 1 II (Before)	4.041 microgram per milliliter Interval 1.542 to 10.593	10.338 microgram per milliliter Interval 1.123 to 95.149	0.185 microgram per milliliter Interval 0.053 to 0.646	—	—	—	—
GMCs of GBS Serotype-specific IgG Before and 1 Month, 3 Months, and 6 Months After a Booster Dose: Non Pregnant Women Stage 1 II (Month 1)	113.187 microgram per milliliter Interval 57.027 to 224.653	92.478 microgram per milliliter Interval 17.542 to 487.53	48.523 microgram per milliliter Interval 10.696 to 220.122	—	—	—	—
GMCs of GBS Serotype-specific IgG Before and 1 Month, 3 Months, and 6 Months After a Booster Dose: Non Pregnant Women Stage 1 II (Month 3)	64.110 microgram per milliliter Interval 31.261 to 131.479	62.160 microgram per milliliter Interval 9.893 to 390.578	32.569 microgram per milliliter Interval 6.968 to 152.225	—	—	—	—
GMCs of GBS Serotype-specific IgG Before and 1 Month, 3 Months, and 6 Months After a Booster Dose: Non Pregnant Women Stage 1 II (Month 6)	38.482 microgram per milliliter Interval 17.354 to 85.334	48.827 microgram per milliliter Interval 7.872 to 302.837	24.262 microgram per milliliter Interval 5.239 to 112.349	—	—	—	—
GMCs of GBS Serotype-specific IgG Before and 1 Month, 3 Months, and 6 Months After a Booster Dose: Non Pregnant Women Stage 1 III (Before)	6.765 microgram per milliliter Interval 1.919 to 23.847	3.058 microgram per milliliter Interval 0.343 to 27.231	0.084 microgram per milliliter Interval 0.017 to 0.403	—	—	—	—
GMCs of GBS Serotype-specific IgG Before and 1 Month, 3 Months, and 6 Months After a Booster Dose: Non Pregnant Women Stage 1 III (Month 1)	36.579 microgram per milliliter Interval 17.516 to 76.39	30.831 microgram per milliliter Interval 11.3 to 84.117	14.092 microgram per milliliter Interval 4.614 to 43.045	—	—	—	—
GMCs of GBS Serotype-specific IgG Before and 1 Month, 3 Months, and 6 Months After a Booster Dose: Non Pregnant Women Stage 1 III (Month 3)	25.006 microgram per milliliter Interval 11.011 to 56.79	18.206 microgram per milliliter Interval 4.216 to 78.614	7.729 microgram per milliliter Interval 2.486 to 24.024	—	—	—	—
GMCs of GBS Serotype-specific IgG Before and 1 Month, 3 Months, and 6 Months After a Booster Dose: Non Pregnant Women Stage 1 III (Month 6)	21.808 microgram per milliliter Interval 9.021 to 52.717	12.540 microgram per milliliter Interval 2.433 to 64.642	4.941 microgram per milliliter Interval 2.015 to 12.117	—	—	—	—
GMCs of GBS Serotype-specific IgG Before and 1 Month, 3 Months, and 6 Months After a Booster Dose: Non Pregnant Women Stage 1 IV (Before)	0.949 microgram per milliliter Interval 0.388 to 2.324	0.351 microgram per milliliter Interval 0.08 to 1.545	0.031 microgram per milliliter Interval 0.006 to 0.151	—	—	—	—
GMCs of GBS Serotype-specific IgG Before and 1 Month, 3 Months, and 6 Months After a Booster Dose: Non Pregnant Women Stage 1 IV (Month 1)	33.784 microgram per milliliter Interval 18.478 to 61.771	14.228 microgram per milliliter Interval 5.724 to 35.368	14.942 microgram per milliliter Interval 5.92 to 37.717	—	—	—	—
GMCs of GBS Serotype-specific IgG Before and 1 Month, 3 Months, and 6 Months After a Booster Dose: Non Pregnant Women Stage 1 IV (Month 3)	14.744 microgram per milliliter Interval 7.275 to 29.882	5.820 microgram per milliliter Interval 2.005 to 16.893	7.524 microgram per milliliter Interval 2.629 to 21.536	—	—	—	—
GMCs of GBS Serotype-specific IgG Before and 1 Month, 3 Months, and 6 Months After a Booster Dose: Non Pregnant Women Stage 1 IV (Month 6)	9.750 microgram per milliliter Interval 4.014 to 23.681	3.325 microgram per milliliter Interval 1.082 to 10.218	4.918 microgram per milliliter Interval 1.606 to 15.057	—	—	—	—
GMCs of GBS Serotype-specific IgG Before and 1 Month, 3 Months, and 6 Months After a Booster Dose: Non Pregnant Women Stage 1 V (Before)	0.245 microgram per milliliter Interval 0.056 to 1.076	0.261 microgram per milliliter Interval 0.026 to 2.596	0.080 microgram per milliliter Interval 0.012 to 0.532	—	—	—	—
GMCs of GBS Serotype-specific IgG Before and 1 Month, 3 Months, and 6 Months After a Booster Dose: Non Pregnant Women Stage 1 V (Month 1)	8.208 microgram per milliliter Interval 2.328 to 28.936	7.177 microgram per milliliter Interval 0.841 to 61.232	6.511 microgram per milliliter Interval 0.665 to 63.696	—	—	—	—
GMCs of GBS Serotype-specific IgG Before and 1 Month, 3 Months, and 6 Months After a Booster Dose: Non Pregnant Women Stage 1 V (Month 3)	4.454 microgram per milliliter Interval 1.177 to 16.857	3.782 microgram per milliliter Interval 0.448 to 31.946	5.400 microgram per milliliter Interval 0.71 to 41.094	—	—	—	—
GMCs of GBS Serotype-specific IgG Before and 1 Month, 3 Months, and 6 Months After a Booster Dose: Non Pregnant Women Stage 1 V (Month 6)	3.086 microgram per milliliter Interval 0.767 to 12.417	2.594 microgram per milliliter Interval 0.314 to 21.411	4.666 microgram per milliliter Interval 0.601 to 36.239	—	—	—	—

SECONDARY outcome

Timeframe: At 2 Weeks after Vaccination, 1 Month After Vaccination and at Delivery

Population: Evaluable immunogenicity population. Here, "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

Serotypes used for evaluation were: Ia, Ib, II, III, IV, and V.

Outcome measures

Outcome measures
Measure	Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) n=39 Participants Nonpregnant participants were randomized to receive a primary of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) n=39 Participants Nonpregnant participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 1: Placebo (Nonpregnant) n=28 Participants Non pregnant participants were randomized to receive placebo (saline control) intramuscularly on Day 1.	Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) n=26 Participants Maternal participants were randomized to receive a single dose of 10 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg With AlPO4 (Maternal) n=39 Participants Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) n=40 Participants Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: Placebo (Maternal) n=103 Participants Maternal participants were randomized to receive placebo (saline control) intramuscularly on Day 1.
GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 Ia (Week 2)	8.399 microgram per milliliter Interval 3.031 to 23.274	16.089 microgram per milliliter Interval 7.267 to 35.623	11.073 microgram per milliliter Interval 3.974 to 30.852	10.782 microgram per milliliter Interval 2.432 to 47.8	13.813 microgram per milliliter Interval 4.502 to 42.381	41.201 microgram per milliliter Interval 20.997 to 80.843	0.099 microgram per milliliter Interval 0.055 to 0.178
GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 Ia (Month 1)	8.850 microgram per milliliter Interval 3.119 to 25.116	14.987 microgram per milliliter Interval 6.881 to 32.64	14.356 microgram per milliliter Interval 4.65 to 44.324	16.283 microgram per milliliter Interval 5.352 to 49.54	17.399 microgram per milliliter Interval 6.456 to 46.894	47.200 microgram per milliliter Interval 29.211 to 76.266	0.092 microgram per milliliter Interval 0.052 to 0.161
GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 Ia (At Delivery)	11.940 microgram per milliliter Interval 5.566 to 25.613	13.901 microgram per milliliter Interval 5.547 to 34.833	14.492 microgram per milliliter Interval 5.244 to 40.045	20.078 microgram per milliliter Interval 7.642 to 52.75	21.991 microgram per milliliter Interval 8.812 to 54.883	39.831 microgram per milliliter Interval 23.254 to 68.225	0.116 microgram per milliliter Interval 0.063 to 0.211
GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 Ib (Week 2)	0.270 microgram per milliliter Interval 0.09 to 0.811	0.306 microgram per milliliter Interval 0.106 to 0.878	0.315 microgram per milliliter Interval 0.077 to 1.282	1.354 microgram per milliliter Interval 0.366 to 5.014	0.698 microgram per milliliter Interval 0.315 to 1.548	1.245 microgram per milliliter Interval 0.454 to 3.414	0.009 microgram per milliliter Interval 0.006 to 0.014
GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 Ib (Month 1)	0.275 microgram per milliliter Interval 0.082 to 0.922	0.382 microgram per milliliter Interval 0.131 to 1.119	0.350 microgram per milliliter Interval 0.098 to 1.248	1.102 microgram per milliliter Interval 0.329 to 3.693	0.566 microgram per milliliter Interval 0.249 to 1.283	1.284 microgram per milliliter Interval 0.491 to 3.362	0.009 microgram per milliliter Interval 0.006 to 0.013
GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 Ib (At Delivery)	0.453 microgram per milliliter Interval 0.155 to 1.329	0.293 microgram per milliliter Interval 0.101 to 0.847	0.625 microgram per milliliter Interval 0.179 to 2.181	1.668 microgram per milliliter Interval 0.558 to 4.989	0.844 microgram per milliliter Interval 0.388 to 1.838	1.388 microgram per milliliter Interval 0.603 to 3.196	0.012 microgram per milliliter Interval 0.008 to 0.017
GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 II (Week 2)	8.153 microgram per milliliter Interval 4.325 to 15.368	5.294 microgram per milliliter Interval 2.942 to 9.525	8.232 microgram per milliliter Interval 3.838 to 17.654	7.933 microgram per milliliter Interval 3.596 to 17.498	16.009 microgram per milliliter Interval 7.878 to 32.536	22.272 microgram per milliliter Interval 10.782 to 46.006	0.095 microgram per milliliter Interval 0.067 to 0.135
GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 II (Month 1)	7.784 microgram per milliliter Interval 3.533 to 17.153	4.555 microgram per milliliter Interval 2.277 to 9.112	10.449 microgram per milliliter Interval 4.742 to 23.026	9.691 microgram per milliliter Interval 5.41 to 17.361	12.468 microgram per milliliter Interval 5.531 to 28.11	27.493 microgram per milliliter Interval 15.334 to 49.295	0.112 microgram per milliliter Interval 0.076 to 0.165
GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 II (At Delivery)	8.676 microgram per milliliter Interval 4.463 to 16.866	3.220 microgram per milliliter Interval 1.509 to 6.872	9.676 microgram per milliliter Interval 4.528 to 20.679	7.158 microgram per milliliter Interval 3.709 to 13.816	15.543 microgram per milliliter Interval 7.816 to 30.907	25.853 microgram per milliliter Interval 14.64 to 45.655	0.139 microgram per milliliter Interval 0.097 to 0.2
GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 III (Week 2)	1.518 microgram per milliliter Interval 0.534 to 4.312	2.165 microgram per milliliter Interval 0.829 to 5.658	4.164 microgram per milliliter Interval 1.236 to 14.033	2.344 microgram per milliliter Interval 0.7 to 7.844	2.117 microgram per milliliter Interval 0.847 to 5.296	4.979 microgram per milliliter Interval 1.87 to 13.26	0.020 microgram per milliliter Interval 0.013 to 0.031
GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 III (Month 1)	1.294 microgram per milliliter Interval 0.432 to 3.878	1.638 microgram per milliliter Interval 0.658 to 4.077	7.260 microgram per milliliter Interval 2.394 to 22.014	3.944 microgram per milliliter Interval 1.428 to 10.895	1.627 microgram per milliliter Interval 0.63 to 4.199	5.674 microgram per milliliter Interval 2.41 to 13.354	0.022 microgram per milliliter Interval 0.014 to 0.034
GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 III (At Delivery)	2.518 microgram per milliliter Interval 0.994 to 6.382	1.657 microgram per milliliter Interval 0.602 to 4.561	6.152 microgram per milliliter Interval 2.063 to 18.348	3.199 microgram per milliliter Interval 1.138 to 8.994	2.591 microgram per milliliter Interval 1.156 to 5.806	6.609 microgram per milliliter Interval 2.877 to 15.182	0.023 microgram per milliliter Interval 0.015 to 0.035
GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 IV (Week 2)	1.219 microgram per milliliter Interval 0.577 to 2.573	0.831 microgram per milliliter Interval 0.408 to 1.693	1.783 microgram per milliliter Interval 0.883 to 3.599	1.912 microgram per milliliter Interval 0.849 to 4.304	2.087 microgram per milliliter Interval 1.187 to 3.671	1.700 microgram per milliliter Interval 0.81 to 3.566	0.009 microgram per milliliter Interval 0.007 to 0.013
GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 IV (Month 1)	1.198 microgram per milliliter Interval 0.534 to 2.687	0.783 microgram per milliliter Interval 0.369 to 1.661	1.563 microgram per milliliter Interval 0.706 to 3.46	2.089 microgram per milliliter Interval 1.004 to 4.347	1.219 microgram per milliliter Interval 0.62 to 2.396	2.442 microgram per milliliter Interval 1.444 to 4.128	0.013 microgram per milliliter Interval 0.009 to 0.018
GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 IV (At Delivery)	1.690 microgram per milliliter Interval 0.915 to 3.121	0.556 microgram per milliliter Interval 0.25 to 1.235	1.624 microgram per milliliter Interval 0.776 to 3.399	1.986 microgram per milliliter Interval 0.893 to 4.416	1.821 microgram per milliliter Interval 1.069 to 3.103	2.469 microgram per milliliter Interval 1.457 to 4.182	0.012 microgram per milliliter Interval 0.009 to 0.017
GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 V (Week 2)	0.114 microgram per milliliter Interval 0.052 to 0.248	0.217 microgram per milliliter Interval 0.08 to 0.587	0.522 microgram per milliliter Interval 0.193 to 1.411	0.839 microgram per milliliter Interval 0.286 to 2.466	0.755 microgram per milliliter Interval 0.365 to 1.564	0.534 microgram per milliliter Interval 0.204 to 1.397	0.014 microgram per milliliter Interval 0.01 to 0.019
GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 V (Month 1)	0.115 microgram per milliliter Interval 0.051 to 0.26	0.222 microgram per milliliter Interval 0.074 to 0.663	0.610 microgram per milliliter Interval 0.213 to 1.743	1.158 microgram per milliliter Interval 0.435 to 3.083	0.750 microgram per milliliter Interval 0.339 to 1.657	0.729 microgram per milliliter Interval 0.293 to 1.817	0.014 microgram per milliliter Interval 0.01 to 0.02
GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 V (At Delivery)	0.188 microgram per milliliter Interval 0.098 to 0.36	0.252 microgram per milliliter Interval 0.087 to 0.732	0.919 microgram per milliliter Interval 0.344 to 2.458	1.462 microgram per milliliter Interval 0.546 to 3.918	0.853 microgram per milliliter Interval 0.413 to 1.759	0.901 microgram per milliliter Interval 0.388 to 2.094	0.016 microgram per milliliter Interval 0.011 to 0.023

SECONDARY outcome

Timeframe: At 2 Weeks after Vaccination, 1 Month After Vaccination and at Delivery

Population: Evaluable immunogenicity population. Here, "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

Serotypes used for evaluation were: Ia, Ib, II, III, IV, and V.

Outcome measures

Outcome measures
Measure	Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) n=102 Participants Nonpregnant participants were randomized to receive a primary of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) n=100 Participants Nonpregnant participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 1: Placebo (Nonpregnant) Non pregnant participants were randomized to receive placebo (saline control) intramuscularly on Day 1.	Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) Maternal participants were randomized to receive a single dose of 10 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg With AlPO4 (Maternal) Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: Placebo (Maternal) Maternal participants were randomized to receive placebo (saline control) intramuscularly on Day 1.
GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 3 Ia (Week 2)	9.233 microgram per milliliter Interval 4.648 to 18.343	0.051 microgram per milliliter Interval 0.027 to 0.096	—	—	—	—	—
GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 3 Ia (Month 1)	9.631 microgram per milliliter Interval 5.178 to 17.914	0.054 microgram per milliliter Interval 0.028 to 0.103	—	—	—	—	—
GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 3 Ia (At Delivery)	8.817 microgram per milliliter Interval 4.969 to 15.643	0.052 microgram per milliliter Interval 0.028 to 0.1	—	—	—	—	—
GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 3 Ib (Week 2)	0.815 microgram per milliliter Interval 0.458 to 1.45	0.009 microgram per milliliter Interval 0.006 to 0.013	—	—	—	—	—
GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 3 Ib (Month 1)	0.832 microgram per milliliter Interval 0.465 to 1.488	0.011 microgram per milliliter Interval 0.007 to 0.016	—	—	—	—	—
GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 3 Ib (At Delivery)	0.645 microgram per milliliter Interval 0.377 to 1.103	0.011 microgram per milliliter Interval 0.007 to 0.016	—	—	—	—	—
GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 3 II (Week 2)	40.234 microgram per milliliter Interval 27.437 to 58.999	0.149 microgram per milliliter Interval 0.103 to 0.216	—	—	—	—	—
GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 3 II (Month 1)	32.831 microgram per milliliter Interval 21.455 to 50.24	0.140 microgram per milliliter Interval 0.096 to 0.204	—	—	—	—	—
GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 3 II (At Delivery)	22.460 microgram per milliliter Interval 14.817 to 34.043	0.146 microgram per milliliter Interval 0.099 to 0.215	—	—	—	—	—
GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 3 III (Week 2)	6.422 microgram per milliliter Interval 3.475 to 11.869	0.034 microgram per milliliter Interval 0.023 to 0.05	—	—	—	—	—
GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 3 III (Month 1)	7.158 microgram per milliliter Interval 4.141 to 12.375	0.034 microgram per milliliter Interval 0.022 to 0.051	—	—	—	—	—
GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 3 III (At Delivery)	5.641 microgram per milliliter Interval 3.486 to 9.129	0.031 microgram per milliliter Interval 0.021 to 0.046	—	—	—	—	—
GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 3 IV (Week 2)	5.719 microgram per milliliter Interval 3.952 to 8.275	0.014 microgram per milliliter Interval 0.009 to 0.02	—	—	—	—	—
GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 3 IV (Month 1)	4.598 microgram per milliliter Interval 3.229 to 6.549	0.014 microgram per milliliter Interval 0.009 to 0.02	—	—	—	—	—
GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 3 IV (At Delivery)	2.708 microgram per milliliter Interval 1.92 to 3.821	0.012 microgram per milliliter Interval 0.009 to 0.018	—	—	—	—	—
GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 3 V (Week 2)	0.760 microgram per milliliter Interval 0.427 to 1.352	0.013 microgram per milliliter Interval 0.009 to 0.017	—	—	—	—	—
GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 3 V (Month 1)	0.732 microgram per milliliter Interval 0.41 to 1.306	0.014 microgram per milliliter Interval 0.01 to 0.02	—	—	—	—	—
GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 3 V (At Delivery)	0.452 microgram per milliliter Interval 0.266 to 0.768	0.012 microgram per milliliter Interval 0.009 to 0.017	—	—	—	—	—

SECONDARY outcome

Timeframe: At 1 Month After Vaccination and at Delivery

Population: Evaluable immunogenicity population. Here, "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

OPA for the 6 serotypes (Ia, Ib, II, III, IV, V) were determined in all participants for each blood sample.

Outcome measures

Outcome measures
Measure	Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) n=39 Participants Nonpregnant participants were randomized to receive a primary of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) n=39 Participants Nonpregnant participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 1: Placebo (Nonpregnant) n=28 Participants Non pregnant participants were randomized to receive placebo (saline control) intramuscularly on Day 1.	Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) n=26 Participants Maternal participants were randomized to receive a single dose of 10 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg With AlPO4 (Maternal) n=39 Participants Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) n=40 Participants Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: Placebo (Maternal) n=103 Participants Maternal participants were randomized to receive placebo (saline control) intramuscularly on Day 1.
GBS6 Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 Ia (Month 1)	13012.1 Titer Interval 8833.7 to 19166.7	7765.3 Titer Interval 4510.1 to 13369.8	14408.2 Titer Interval 8688.7 to 23892.6	9722.0 Titer Interval 5042.9 to 18742.6	8133.8 Titer Interval 3884.6 to 17031.1	23271.2 Titer Interval 16886.0 to 32070.9	200.2 Titer Interval 148.1 to 270.6
GBS6 Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 Ia (At delivery)	10500.3 Titer Interval 5750.8 to 19172.5	7160.6 Titer Interval 4139.7 to 12386.1	7560.6 Titer Interval 4145.9 to 13788.0	10501.6 Titer Interval 5084.2 to 21691.3	11820.6 Titer Interval 6122.2 to 22822.9	13037.0 Titer Interval 8256.0 to 20586.8	228.0 Titer Interval 159.7 to 325.4
GBS6 Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 Ib (Month 1)	11534.8 Titer Interval 6127.3 to 21714.3	10639.1 Titer Interval 5992.3 to 18889.3	9835.4 Titer Interval 4446.4 to 21755.7	9031.8 Titer Interval 3780.8 to 21575.3	13747.4 Titer Interval 7723.3 to 24470.3	20896.2 Titer Interval 12772.3 to 34187.4	864.9 Titer Interval 592.5 to 1262.5
GBS6 Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 Ib (At delivery)	14876.0 Titer Interval 6608.3 to 33487.9	12259.3 Titer Interval 6958.6 to 21597.9	14665.8 Titer Interval 6990.4 to 30768.4	10741.1 Titer Interval 4206.8 to 27425.2	16005.8 Titer Interval 8790.7 to 29142.9	19050.4 Titer Interval 10640.3 to 34107.8	794.2 Titer Interval 512.8 to 1230.2
GBS6 Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 II (Month 1)	9908.6 Titer Interval 6649.3 to 14765.6	5486.1 Titer Interval 3655.7 to 8232.9	16560.9 Titer Interval 9736.9 to 28167.2	8564.5 Titer Interval 4974.9 to 14744.2	9693.4 Titer Interval 6287.5 to 14944.5	22480.0 Titer Interval 14472.6 to 34917.9	856.3 Titer Interval 641.7 to 1142.6
GBS6 Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 II (At delivery)	9573.5 Titer Interval 5948.3 to 15408.0	6521.0 Titer Interval 3963.2 to 10729.7	18640.8 Titer Interval 13002.6 to 26723.8	9305.9 Titer Interval 5201.3 to 16649.7	13197.3 Titer Interval 8444.8 to 20624.3	19559.7 Titer Interval 11908.5 to 32126.9	1012.0 Titer Interval 742.7 to 1378.8
GBS6 Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 III (Month 1)	4026.7 Titer Interval 2234.9 to 7255.0	3285.5 Titer Interval 1802.0 to 5990.4	11207.9 Titer Interval 5496.5 to 22854.0	3884.7 Titer Interval 2298.0 to 6567.2	4829.8 Titer Interval 2615.6 to 8918.4	7463.5 Titer Interval 4309.8 to 12924.7	547.2 Titer Interval 398.6 to 751.2
GBS6 Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 III (At delivery)	5105.3 Titer Interval 2701.9 to 9646.8	3959.5 Titer Interval 2200.6 to 7124.3	5229.1 Titer Interval 2638.7 to 10362.5	3850.2 Titer Interval 1890.0 to 7843.4	5669.2 Titer Interval 3175.7 to 10120.4	5209.2 Titer Interval 2752.3 to 9859.5	429.6 Titer Interval 300.8 to 5209.2
GBS6 Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 IV (Month 1)	6591.5 Titer Interval 4596.8 to 9451.9	6087.6 Titer Interval 4249.5 to 8720.9	8773.7 Titer Interval 5381.7 to 14303.7	7862.5 Titer Interval 4642.8 to 13315.3	6576.7 Titer Interval 4303.1 to 10051.7	8570.4 Titer Interval 5776.1 to 12716.5	1303.1 Titer Interval 993.3 to 1709.4
GBS6 Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 IV (At delivery)	8074.3 Titer Interval 5019.7 to 12987.6	6302.6 Titer Interval 4344.3 to 9143.7	7713.8 Titer Interval 5537.3 to 10745.9	7494.3 Titer Interval 4144.7 to 13551.0	7557.0 Titer Interval 5062.9 to 11279.9	7316.2 Titer Interval 4995.8 to 10714.5	1146.0 Titer Interval 851.4 to 1542.4
GBS6 Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 V (Month 1)	3048.0 Titer Interval 2012.8 to 4615.7	5568.4 Titer Interval 3485.6 to 8896.0	7288.6 Titer Interval 3896.5 to 13633.6	5272.9 Titer Interval 2895.9 to 9600.9	4359.2 Titer Interval 2741.0 to 6932.6	5607.4 Titer Interval 3761.8 to 8358.4	790.8 Titer Interval 545.4 to 1146.6
GBS6 Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 V (At delivery)	2450.4 Titer Interval 1564.1 to 3839.0	3109.0 Titer Interval 1777.9 to 5436.6	6309.7 Titer Interval 3524.3 to 11296.3	2145.3 Titer Interval 2145.3 to 7367.4	4642.9 Titer Interval 2857.4 to 7544.2	5364.8 Titer Interval 3361.9 to 8560.7	649.1 Titer Interval 443.5 to 949.9

SECONDARY outcome

Timeframe: At 1 Month After Vaccination and at Delivery

Population: Evaluable immunogenicity population. Here, "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

OPA for the 6 serotypes (Ia, Ib, II, III, IV, V) were determined in all participants for each blood sample.

Outcome measures

Outcome measures
Measure	Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) n=102 Participants Nonpregnant participants were randomized to receive a primary of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) n=100 Participants Nonpregnant participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 1: Placebo (Nonpregnant) Non pregnant participants were randomized to receive placebo (saline control) intramuscularly on Day 1.	Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) Maternal participants were randomized to receive a single dose of 10 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg With AlPO4 (Maternal) Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: Placebo (Maternal) Maternal participants were randomized to receive placebo (saline control) intramuscularly on Day 1.
GBS6 Serotype-Specific OPA Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 3 Ia: at 1 month	11462.9 Titer Interval 7717.7 to 17025.6	196.1 Titer Interval 143.3 to 268.5	—	—	—	—	—
GBS6 Serotype-Specific OPA Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 3 Ia: at delivery	6228.2 Titer Interval 3987.0 to 9729.2	211.4 Titer Interval 146.0 to 306.0	—	—	—	—	—
GBS6 Serotype-Specific OPA Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 3 Ib: at 1 month	13306.1 Titer Interval 9230.1 to 19182.2	480.8 Titer Interval 316.5 to 730.3	—	—	—	—	—
GBS6 Serotype-Specific OPA Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 3 Ib: at delivery	7011.6 Titer Interval 4414.7 to 11136.1	481.6 Titer Interval 314.6 to 737.1	—	—	—	—	—
GBS6 Serotype-Specific OPA Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 3 II: at 1 month	35652.7 Titer Interval 27220.2 to 46697.5	1911.7 Titer Interval 1381.8 to 2644.6	—	—	—	—	—
GBS6 Serotype-Specific OPA Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 3 II: at delivery	22650.9 Titer Interval 16845.7 to 30456.6	1998.5 Titer Interval 1418.4 to 2816.0	—	—	—	—	—
GBS6 Serotype-Specific OPA Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 3 III: at 1 month	9064.7 Titer Interval 6412.0 to 12814.8	511.9 Titer Interval 362.8 to 722.3	—	—	—	—	—
GBS6 Serotype-Specific OPA Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 3 III: at delivery	5822.1 Titer Interval 3929.9 to 8625.3	561.7 Titer Interval 392.2 to 804.6	—	—	—	—	—
GBS6 Serotype-Specific OPA Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 3 IV: at 1 month	11800.6 Titer Interval 9297.8 to 14977.0	1152.1 Titer Interval 854.6 to 1553.2	—	—	—	—	—
GBS6 Serotype-Specific OPA Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 3 IV: at delivery	8242.0 Titer Interval 6327.8 to 10735.1	1164.0 Titer Interval 837.9 to 1617.0	—	—	—	—	—
GBS6 Serotype-Specific OPA Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 3 V: at 1 month	9258.1 Titer Interval 7138.7 to 12006.7	846.0 Titer Interval 569.0 to 1257.9	—	—	—	—	—
GBS6 Serotype-Specific OPA Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 3 V: at delivery	5501.3 Titer Interval 3875.7 to 7808.6	837.5 Titer Interval 530.6 to 1322.0	—	—	—	—	—

SECONDARY outcome

Timeframe: At Birth

Population: Evaluable immunogenicity population. Here, "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

Serotypes used for evaluation were: Ia, Ib, II, III, IV, and V.

Outcome measures

Outcome measures
Measure	Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) n=36 Participants Nonpregnant participants were randomized to receive a primary of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) n=30 Participants Nonpregnant participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 1: Placebo (Nonpregnant) n=31 Participants Non pregnant participants were randomized to receive placebo (saline control) intramuscularly on Day 1.	Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) n=31 Participants Maternal participants were randomized to receive a single dose of 10 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg With AlPO4 (Maternal) n=36 Participants Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) n=38 Participants Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: Placebo (Maternal) n=99 Participants Maternal participants were randomized to receive placebo (saline control) intramuscularly on Day 1.
GMCs of GBS6 Serotype-Specific IgG Infant Participant at Birth: Infant Participants Stage 2 Ia	4.322 Microgram per milliliter Interval 1.291 to 14.471	10.978 Microgram per milliliter Interval 4.362 to 27.625	6.128 Microgram per milliliter Interval 0.996 to 37.71	11.089 Microgram per milliliter Interval 1.919 to 64.083	6.094 Microgram per milliliter Interval 1.435 to 25.87	22.159 Microgram per milliliter Interval 11.705 to 41.949	0.047 Microgram per milliliter Interval 0.025 to 0.091
GMCs of GBS6 Serotype-Specific IgG Infant Participant at Birth: Infant Participants Stage 2 Ib	0.155 Microgram per milliliter Interval 0.034 to 0.712	0.182 Microgram per milliliter Interval 0.045 to 0.727	0.481 Microgram per milliliter Interval 0.056 to 4.113	0.427 Microgram per milliliter Interval 0.083 to 2.206	0.253 Microgram per milliliter Interval 0.084 to 0.766	0.655 Microgram per milliliter Interval 0.217 to 1.976	0.007 Microgram per milliliter Interval 0.005 to 0.011
GMCs of GBS6 Serotype-Specific IgG Infant Participant at Birth: Infant Participants Stage 2 II	7.680 Microgram per milliliter Interval 2.851 to 20.69	1.935 Microgram per milliliter Interval 1.009 to 3.711	5.190 Microgram per milliliter Interval 1.314 to 20.507	4.522 Microgram per milliliter Interval 1.393 to 14.68	12.594 Microgram per milliliter Interval 4.814 to 32.948	16.979 Microgram per milliliter Interval 8.465 to 34.057	0.080 Microgram per milliliter Interval 0.054 to 0.117
GMCs of GBS6 Serotype-Specific IgG Infant Participant at Birth: Infant Participants Stage 2 III	0.954 Microgram per milliliter Interval 0.219 to 4.148	1.009 Microgram per milliliter Interval 0.289 to 3.521	0.917 Microgram per milliliter Interval 0.118 to 7.109	0.906 Microgram per milliliter Interval 0.208 to 3.954	1.085 Microgram per milliliter Interval 0.302 to 3.902	3.417 Microgram per milliliter Interval 1.495 to 7.81	0.017 Microgram per milliliter Interval 0.011 to 0.026
GMCs of GBS6 Serotype-Specific IgG Infant Participant at Birth: Infant Participants Stage 2 IV	0.993 Microgram per milliliter Interval 0.403 to 2.447	0.448 Microgram per milliliter Interval 0.165 to 1.215	0.759 Microgram per milliliter Interval 0.275 to 2.098	0.550 Microgram per milliliter Interval 0.193 to 1.564	1.104 Microgram per milliliter Interval 0.454 to 2.684	1.903 Microgram per milliliter Interval 1.033 to 3.505	0.007 Microgram per milliliter Interval 0.005 to 0.009
GMCs of GBS6 Serotype-Specific IgG Infant Participant at Birth: Infant Participants Stage 2 V	0.084 Microgram per milliliter Interval 0.031 to 0.226	0.090 Microgram per milliliter Interval 0.025 to 0.327	0.183 Microgram per milliliter Interval 0.054 to 0.618	1.255 Microgram per milliliter Interval 0.267 to 5.908	0.327 Microgram per milliliter Interval 0.123 to 0.871	0.502 Microgram per milliliter Interval 0.199 to 1.267	0.010 Microgram per milliliter Interval 0.007 to 0.015

SECONDARY outcome

Timeframe: At Birth

Population: Evaluable immunogenicity population. Here, "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

Serotypes used for evaluation were: Ia, Ib, II, III, IV, and V.

Outcome measures

Outcome measures
Measure	Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) n=86 Participants Nonpregnant participants were randomized to receive a primary of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) n=88 Participants Nonpregnant participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 1: Placebo (Nonpregnant) Non pregnant participants were randomized to receive placebo (saline control) intramuscularly on Day 1.	Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) Maternal participants were randomized to receive a single dose of 10 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg With AlPO4 (Maternal) Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: Placebo (Maternal) Maternal participants were randomized to receive placebo (saline control) intramuscularly on Day 1.
GMCs of GBS6 Serotype-Specific IgG Infant Participant at Birth: Infant Participants Stage 3 Ia	6.366 Microgram per milliliter Interval 3.343 to 12.122	0.048 Microgram per milliliter Interval 0.026 to 0.089	—	—	—	—	—
GMCs of GBS6 Serotype-Specific IgG Infant Participant at Birth: Infant Participants Stage 3 Ib	0.466 Microgram per milliliter Interval 0.261 to 0.833	0.009 Microgram per milliliter Interval 0.006 to 0.014	—	—	—	—	—
GMCs of GBS6 Serotype-Specific IgG Infant Participant at Birth: Infant Participants Stage 3 II	16.123 Microgram per milliliter Interval 10.03 to 25.916	0.134 Microgram per milliliter Interval 0.09 to 0.201	—	—	—	—	—
GMCs of GBS6 Serotype-Specific IgG Infant Participant at Birth: Infant Participants Stage 3 III	3.609 Microgram per milliliter Interval 2.076 to 6.275	0.024 Microgram per milliliter Interval 0.016 to 0.036	—	—	—	—	—
GMCs of GBS6 Serotype-Specific IgG Infant Participant at Birth: Infant Participants Stage 3 IV	2.124 Microgram per milliliter Interval 1.391 to 3.243	0.013 Microgram per milliliter Interval 0.009 to 0.02	—	—	—	—	—
GMCs of GBS6 Serotype-Specific IgG Infant Participant at Birth: Infant Participants Stage 3 V	0.278 Microgram per milliliter Interval 0.16 to 0.481	0.011 Microgram per milliliter Interval 0.008 to 0.015	—	—	—	—	—

SECONDARY outcome

Timeframe: At Birth

Population: Evaluable immunogenicity population.Here, "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

Serotypes used for evaluation were: Ia, Ib, II, III, IV, and V.

Outcome measures

Outcome measures
Measure	Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) n=36 Participants Nonpregnant participants were randomized to receive a primary of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) n=30 Participants Nonpregnant participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 1: Placebo (Nonpregnant) n=31 Participants Non pregnant participants were randomized to receive placebo (saline control) intramuscularly on Day 1.	Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) n=31 Participants Maternal participants were randomized to receive a single dose of 10 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg With AlPO4 (Maternal) n=36 Participants Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) n=38 Participants Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: Placebo (Maternal) n=99 Participants Maternal participants were randomized to receive placebo (saline control) intramuscularly on Day 1.
GBS6 Serotype-Specific OPA GMTs Measured at Birth: Infant Participants Stage 2 Ia	991.5 Titer Interval 428.9 to 2291.8	2116.3 Titer Interval 952.2 to 4703.4	1927.4 Titer Interval 792.8 to 4686.0	3053.1 Titer Interval 1203.9 to 7742.2	1459.1 Titer Interval 464.1 to 4587.1	7916.5 Titer Interval 4001.6 to 15661.4	91.3 Titer Interval 77.0 to 108.3
GBS6 Serotype-Specific OPA GMTs Measured at Birth: Infant Participants Stage 2 Ib	410.3 Titer Interval 159.2 to 1057.5	357.2 Titer Interval 122.4 to 1042.1	986.5 Titer Interval 297.8 to 3268.6	1160.5 Titer Interval 411.1 to 3276.0	451.1 Titer Interval 190.9 to 1066.1	1879.2 Titer Interval 632.9 to 5579.7	137.1 Titer Interval 97.7 to 192.4
GBS6 Serotype-Specific OPA GMTs Measured at Birth: Infant Participants Stage 2 II	440.3 Titer Interval 251.6 to 770.6	399.5 Titer Interval 212.8 to 750.0	689.0 Titer Interval 313.0 to 1516.8	606.8 Titer Interval 242.7 to 1517.1	1049.9 Titer Interval 440.7 to 2501.3	3262.2 Titer Interval 1355.4 to 7851.6	212.8 Titer Interval 186.2 to 243.3
GBS6 Serotype-Specific OPA GMTs Measured at Birth: Infant Participants Stage 2 III	452.2 Titer Interval 203.9 to 1003.0	249.1 Titer Interval 119.0 to 521.4	698.4 Titer Interval 205.7 to 2371.5	479.0 Titer Interval 175.0 to 1311.3	634.2 Titer Interval 267.5 to 1503.2	766.9 Titer Interval 323.4 to 1818.7	79.2 Titer Interval 67.9 to 92.4
GBS6 Serotype-Specific OPA GMTs Measured at Birth: Infant Participants Stage 2 IV	276.7 Titer Interval 174.6 to 438.4	379.3 Titer Interval 160.4 to 897.0	258.8 Titer Interval 170.3 to 393.2	439.2 Titer Interval 220.2 to 875.7	438.8 Titer Interval 195.6 to 984.5	1071.2 Titer Interval 484.0 to 2370.8	157.2 Titer Interval 122.8 to 201.3
GBS6 Serotype-Specific OPA GMTs Measured at Birth: Infant Participants Stage 2 V	91.2 Titer Interval 67.3 to 123.8	162.4 Titer Interval 78.7 to 335.4	143.7 Titer Interval 71.5 to 289.1	521.2 Titer Interval 193.8 to 1401.3	219.1 Titer Interval 90.5 to 530.8	1189.4 Titer Interval 440.5 to 3211.4	98.3 Titer Interval 74.3 to 129.9

SECONDARY outcome

Timeframe: At Birth

Population: Evaluable immunogenicity population. Here, "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

Serotypes used for evaluation were: Ia, Ib, II, III, IV, and V.

Outcome measures

Outcome measures
Measure	Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) n=86 Participants Nonpregnant participants were randomized to receive a primary of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) n=88 Participants Nonpregnant participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 1: Placebo (Nonpregnant) Non pregnant participants were randomized to receive placebo (saline control) intramuscularly on Day 1.	Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) Maternal participants were randomized to receive a single dose of 10 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg With AlPO4 (Maternal) Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: Placebo (Maternal) Maternal participants were randomized to receive placebo (saline control) intramuscularly on Day 1.
GBS6 Serotype-Specific OPA GMTs Measured at Birth: Infant Participants Stage 3 Ia	1173.7 Titer Interval 659.3 to 2089.1	89.5 Titer Interval 75.0 to 106.7	—	—	—	—	—
GBS6 Serotype-Specific OPA GMTs Measured at Birth: Infant Participants Stage 3 Ib	1108.3 Titer Interval 590.7 to 2079.3	114.8 Titer Interval 90.1 to 146.3	—	—	—	—	—
GBS6 Serotype-Specific OPA GMTs Measured at Birth: Infant Participants Stage 3 II	3639.4 Titer Interval 2310.4 to 5732.9	291.0 Titer Interval 219.3 to 386.1	—	—	—	—	—
GBS6 Serotype-Specific OPA GMTs Measured at Birth: Infant Participants Stage 3 III	1005.6 Titer Interval 571.1 to 1770.5	77.1 Titer Interval 66.0 to 90.1	—	—	—	—	—
GBS6 Serotype-Specific OPA GMTs Measured at Birth: Infant Participants Stage 3 IV	854.0 Titer Interval 550.4 to 1325.1	160.2 Titer Interval 128.7 to 199.4	—	—	—	—	—
GBS6 Serotype-Specific OPA GMTs Measured at Birth: Infant Participants Stage 3 V	393.8 Titer Interval 227.6 to 681.3	127.8 Titer Interval 90.6 to 180.2	—	—	—	—	—

Adverse Events

Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant)

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant)

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Stage 1: Placebo (Nonpregnant)

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

Stage 1 Booster: GBS6 20 mcg With AlPO4 (Nonpregnant)

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Stage 1 Booster: GBS6 20 mcg Without AlPO4 (Nonpregnant)

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Stage 1 Booster: Placebo (Nonpregnant)

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Stage 2: GBS6 5 mcg With AlPO4 (Maternal)

Serious events: 7 serious events

Other events: 30 other events

Deaths: 0 deaths

Stage 2: GBS6 5 mcg Without AlPO4 (Maternal)

Serious events: 18 serious events

Other events: 36 other events

Deaths: 0 deaths

Stage 2: GBS6 10 mcg With AlPO4 (Maternal)

Serious events: 9 serious events

Other events: 31 other events

Deaths: 0 deaths

Stage 2: GBS6 10 mcg Without AlPO4 (Maternal)

Serious events: 11 serious events

Other events: 27 other events

Deaths: 0 deaths

Stage 2: GBS6 20 mcg With AlPO4 (Maternal)

Serious events: 8 serious events

Other events: 34 other events

Deaths: 0 deaths

Stage 2: GBS6 20 mcg Without AlPO4 (Maternal)

Serious events: 14 serious events

Other events: 36 other events

Deaths: 0 deaths

Stage 2: Placebo (Maternal)

Serious events: 30 serious events

Other events: 98 other events

Deaths: 1 deaths

Stage 2: GBS6 5 mcg With AlPO4 (Infant)

Serious events: 17 serious events

Other events: 27 other events

Deaths: 0 deaths

Stage 2: GBS6 5 mcg Without AlPO4 (Infant)

Serious events: 19 serious events

Other events: 19 other events

Deaths: 1 deaths

Stage 2: GBS6 10 mcg With AlPO4 (Infant)

Serious events: 15 serious events

Other events: 22 other events

Deaths: 0 deaths

Stage 2: GBS6 10 mcg Without AlPO4 (Infant)

Serious events: 12 serious events

Other events: 26 other events

Deaths: 0 deaths

Stage 2: GBS6 20 mcg With AlPO4 (Infant)

Serious events: 19 serious events

Other events: 20 other events

Deaths: 0 deaths

Stage 2: GBS6 20 mcg Without AlPO4 (Infant)

Serious events: 14 serious events

Other events: 21 other events

Deaths: 0 deaths

Stage 2: Placebo (Infant)

Serious events: 60 serious events

Other events: 66 other events

Deaths: 2 deaths

Stage 3: GBS6 20 mcg Without AlPO4 (Maternal)

Serious events: 21 serious events

Other events: 91 other events

Deaths: 0 deaths

Stage 3: Placebo (Maternal)

Serious events: 23 serious events

Other events: 90 other events

Deaths: 0 deaths

Stage 3: GBS6 20 mcg Without AlPO4 (Infant)

Serious events: 45 serious events

Other events: 78 other events

Deaths: 3 deaths

Stage 3: Placebo (Infant)

Serious events: 46 serious events

Other events: 81 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) n=22 participants at risk Nonpregnant participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) n=22 participants at risk Nonpregnant participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 1: Placebo (Nonpregnant) n=22 participants at risk Non pregnant participants were randomized to receive placebo (saline control) intramuscularly on Day 1.	Stage 1 Booster: GBS6 20 mcg With AlPO4 (Nonpregnant) n=11 participants at risk Non pregnant participants were randomized to receive a booster dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly at least 2 years after Vaccination 1 on Day 1. Participants were categorized based on their primary dose of GBS6 vaccine with AlPO4.	Stage 1 Booster: GBS6 20 mcg Without AlPO4 (Nonpregnant) n=7 participants at risk Non pregnant participants were randomized to receive a booster dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly at least 2 years after Vaccination 1 on Day 1. Participants were categorized based on their primary dose of GBS6 vaccine without AlPO4.	Stage 1 Booster: Placebo (Nonpregnant) n=8 participants at risk Non pregnant participants were randomized to receive a booster dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly at least 2 years after Vaccination 1 on Day 1. Participants were categorized based on their primary dose of Placebo.	Stage 2: GBS6 5 mcg With AlPO4 (Maternal) n=40 participants at risk Maternal participants were randomized to receive a single dose of 5 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 5 mcg Without AlPO4 (Maternal) n=40 participants at risk Maternal participants were randomized to receive a single dose of 5 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 10 mcg With AlPO4 (Maternal) n=40 participants at risk Maternal participants were randomized to receive a single dose of 10 μg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) n=40 participants at risk Maternal participants were randomized to receive a single dose of 10 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg With AlPO4 (Maternal) n=40 participants at risk Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) n=40 participants at risk Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: Placebo (Maternal) n=120 participants at risk Maternal participants were randomized to receive placebo (saline control) intramuscularly on Day 1.	Stage 2: GBS6 5 mcg With AlPO4 (Infant) n=40 participants at risk Infant participants born to the maternal participants randomized to receive a single dose of 5 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 5 mcg Without AlPO4 (Infant) n=39 participants at risk Infant participants born to the maternal participants randomized to receive a single dose of 5 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 10 mcg With AlPO4 (Infant) n=40 participants at risk Infant participants born to the maternal participants randomized to receive a single dose of 10 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 10 mcg Without AlPO4 (Infant) n=40 participants at risk Infant participants born to the maternal participants randomized to receive a single dose of 10 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg With AlPO4 (Infant) n=40 participants at risk Infant participants born to the maternal participants randomized to receive a single dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg Without AlPO4 (Infant) n=40 participants at risk Infant participants born to the maternal participants randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: Placebo (Infant) n=118 participants at risk Infant participants born to the maternal participants randomized to receive placebo (saline control) intramuscularly on Day 1.	Stage 3: GBS6 20 mcg Without AlPO4 (Maternal) n=108 participants at risk Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 3: Placebo (Maternal) n=108 participants at risk Maternal participants were randomized to receive placebo (saline control) intramuscularly on Day 1	Stage 3: GBS6 20 mcg Without AlPO4 (Infant) n=104 participants at risk Infant participants born to the maternal participants randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 3: Placebo (Infant) n=105 participants at risk Infant participants born to the maternal participants randomized to receive placebo (saline control) intramuscularly on Day 1.
Immune system disorders Hypersensitivity	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Blood and lymphatic system disorders Anemia	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	25.0% 10/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.96% 1/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Cardiac disorders Tachycardia	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.83% 1/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Endocrine disorders Hypothyroidism	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Gastrointestinal disorders Abdominal pain lower	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Hepatobiliary disorders Biliary colic	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Amniotic cavity infection	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Appendicitis	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Bartholin's abscess	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Klebsiella urinary tract infection	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.83% 1/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Lower respiratory tract infection	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.6% 1/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 3/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.96% 1/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	1.9% 2/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Pneumonia	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	1.7% 2/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.96% 1/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.95% 1/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Postoperative wound infection	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Postpartum sepsis	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Wound infection	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
General disorders Wound sepsis	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.83% 1/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Injury, poisoning and procedural complications Injury	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.83% 1/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.85% 1/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Nervous system disorders Epilepsy	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Pregnancy, puerperium and perinatal conditions Pre-eclampsia	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	5.0% 2/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 3/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	3.7% 4/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Pregnancy, puerperium and perinatal conditions Arrested labour	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.83% 1/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Pregnancy, puerperium and perinatal conditions Breech delivery	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Pregnancy, puerperium and perinatal conditions Cephalo-pelvic disproportion	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	1.7% 2/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Pregnancy, puerperium and perinatal conditions Failed induction of labour	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	5.0% 2/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	1.7% 2/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Pregnancy, puerperium and perinatal conditions Foetal distress syndrome	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	10.0% 4/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	17.5% 7/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	7.5% 3/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	22.5% 9/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	10.0% 4/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	15.0% 6/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	9.2% 11/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	8.3% 9/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	13.0% 14/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Pregnancy, puerperium and perinatal conditions Foetal growth restriction	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Pregnancy, puerperium and perinatal conditions Foetal malpresentation	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Pregnancy, puerperium and perinatal conditions Gestational hypertension	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	5.0% 2/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	5.8% 7/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	1.9% 2/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.8% 3/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Pregnancy, puerperium and perinatal conditions HELLP syndrome	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Pregnancy, puerperium and perinatal conditions Haemorrhage in pregnancy	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Pregnancy, puerperium and perinatal conditions Meconium stain	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.83% 1/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Pregnancy, puerperium and perinatal conditions Placenta praevia	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.83% 1/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Pregnancy, puerperium and perinatal conditions Postpartum haemorrhage	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	5.0% 2/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	1.7% 2/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	1.9% 2/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Pregnancy, puerperium and perinatal conditions Premature delivery	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Pregnancy, puerperium and perinatal conditions Premature rupture of membranes	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.83% 1/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Pregnancy, puerperium and perinatal conditions Preterm premature rupture of membranes	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Pregnancy, puerperium and perinatal conditions Prolonged labour	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	5.0% 2/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.83% 1/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.8% 3/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Pregnancy, puerperium and perinatal conditions Prolonged pregnancy	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Pregnancy, puerperium and perinatal conditions Prolonged rupture of membranes	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	5.0% 2/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	5.0% 2/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 3/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	1.9% 2/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Pregnancy, puerperium and perinatal conditions Retained products of conception	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Pregnancy, puerperium and perinatal conditions Stillbirth	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Metabolism and nutrition disorders Poor feeding infant	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.85% 1/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Psychiatric disorders Depression suicidal	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Psychiatric disorders Generalised anxiety disorder	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.83% 1/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Reproductive system and breast disorders Pelvic haematoma	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Congenital, familial and genetic disorders Accessory auricle	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Congenital, familial and genetic disorders Birth mark	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	4.2% 5/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Congenital, familial and genetic disorders Cardiac malposition	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.85% 1/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	1.9% 2/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.95% 1/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Congenital, familial and genetic disorders Cerebral palsy	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.6% 1/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.85% 1/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Congenital, familial and genetic disorders Congenital cyst	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Congenital, familial and genetic disorders Congenital hiatus hernia	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Congenital, familial and genetic disorders Congenital inguinal hernia	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.85% 1/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.95% 1/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Congenital, familial and genetic disorders Congenital naevus	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	15.0% 6/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	5.1% 2/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	7.5% 3/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	12.5% 5/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	20.0% 8/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	7.5% 3/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	16.9% 20/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	14.4% 15/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	14.3% 15/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Congenital, familial and genetic disorders Congenital umbilical hernia	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	22.5% 9/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	28.2% 11/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	12.5% 5/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	22.5% 9/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	25.0% 10/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	12.5% 5/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	16.9% 20/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	19.2% 20/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	12.4% 13/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Congenital, familial and genetic disorders Gastrointestinal disorder congenital	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Congenital, familial and genetic disorders Haemangioma congenital	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.6% 1/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Congenital, familial and genetic disorders Heart disease congenital	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.85% 1/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Congenital, familial and genetic disorders Hypoplastic left heart syndrome	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.6% 1/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Congenital, familial and genetic disorders Polydactyly	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	7.5% 3/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.85% 1/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.96% 1/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.95% 1/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Congenital, familial and genetic disorders Talipes	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.85% 1/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.96% 1/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Gastrointestinal disorders Tooth development disorder	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.85% 1/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Gastrointestinal disorders Umbilical hernia	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
General disorders Developmental delay	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.6% 1/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	9.3% 10/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Bronchiolitis	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.85% 1/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	1.9% 2/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Conjunctivitis	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	5.0% 2/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Pneumonia aspiration	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.6% 1/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Pneumonia cytomegaloviral	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Pneumonia respiratory syncytial viral	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.96% 1/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Pulmonary tuberculosis	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.85% 1/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Sepsis	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	1.9% 2/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.96% 1/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Sepsis neonatal	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.96% 1/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	4.8% 5/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Staphylococcal sepsis	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Urinary tract infection neonatal	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Metabolism and nutrition disorders Failure to thrive	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.96% 1/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Metabolism and nutrition disorders Feeding intolerance	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.85% 1/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	5.0% 2/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Metabolism and nutrition disorders Hypoglycaemia neonatal	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.6% 1/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.85% 1/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	1.9% 2/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	1.9% 2/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	3.8% 4/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Metabolism and nutrition disorders Malnutrition	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	1.7% 2/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Musculoskeletal and connective tissue disorders Knee deformity	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Musculoskeletal and connective tissue disorders Rickets	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.6% 1/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Haemangioma	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.6% 1/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Nervous system disorders Encephalopathy neonatal	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.6% 1/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	1.7% 2/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.96% 1/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Nervous system disorders Generalised tonic-clonic seizure	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.85% 1/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Nervous system disorders Hypoxic-ischaemic encephalopathy	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.96% 1/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.95% 1/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Nervous system disorders Seizure	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.85% 1/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.96% 1/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Nervous system disorders Subarachnoid haemorrhage	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Pregnancy, puerperium and perinatal conditions Jaundice neonatal	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	7.5% 3/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	10.3% 4/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	5.0% 2/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	10.0% 4/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	5.1% 6/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	3.8% 4/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Pregnancy, puerperium and perinatal conditions Low birth weight baby	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.85% 1/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	1.9% 2/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Pregnancy, puerperium and perinatal conditions Premature baby	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.6% 1/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.96% 1/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	3.8% 4/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Renal and urinary disorders Haematuria	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.85% 1/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Respiratory, thoracic and mediastinal disorders Infantile apnoea	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Respiratory, thoracic and mediastinal disorders Meconium aspiration syndrome	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.96% 1/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	1.9% 2/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Respiratory, thoracic and mediastinal disorders Neonatal respiratory distress	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.96% 1/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	1.9% 2/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Respiratory, thoracic and mediastinal disorders Neonatal respiratory distress syndrome	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	5.1% 2/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.9% 3/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	1.9% 2/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.85% 1/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.6% 1/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.85% 1/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Skin and subcutaneous tissue disorders Cafe au lait spots	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	5.1% 2/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	5.1% 6/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	1.9% 2/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.95% 1/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Skin and subcutaneous tissue disorders Skin lesion	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.85% 1/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Cardiac disorders Tachycardia foetal	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	1.9% 2/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Hepatobiliary disorders Cholelithiasis	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Injury, poisoning and procedural complications Anaemia postoperative	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Injury, poisoning and procedural complications Uterine rupture	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Pregnancy, puerperium and perinatal conditions Foetal death	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Pregnancy, puerperium and perinatal conditions Foetal hypokinesia	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Pregnancy, puerperium and perinatal conditions Premature labour	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Psychiatric disorders Perinatal depression	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Renal and urinary disorders Bladder pain	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Congenital, familial and genetic disorders Cryptorchism	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	1.9% 2/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Congenital, familial and genetic disorders Developmental hip dysplasia	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.95% 1/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Congenital, familial and genetic disorders Eyelid ptosis congenital	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.96% 1/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Congenital, familial and genetic disorders Factor VIII deficiency	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.95% 1/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Congenital, familial and genetic disorders Preauricular cyst	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.96% 1/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Gastrointestinal disorders Intussusception	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.95% 1/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Gastrointestinal disorders Necrotising colitis	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	1.9% 2/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.95% 1/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Gastrointestinal disorders Neonatal gastrointestinal disorder	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.96% 1/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Gastrointestinal disorders Oesophagitis	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	22.5% 9/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	22.5% 9/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	22.5% 9/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	7.5% 9/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	22.5% 9/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	23.1% 9/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	22.5% 9/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	22.5% 9/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.96% 1/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
General disorders Peripheral swelling	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.95% 1/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
General disorders Sudden infant death syndrome	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.96% 1/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.95% 1/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Hepatobiliary disorders Hyperbilirubinaemia neonatal	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.96% 1/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Adenoviral conjunctivitis	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.96% 1/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Adenoviral upper respiratory infection	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.96% 1/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Escherichia bacteraemia	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.83% 1/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.95% 1/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Gastroenteritis adenovirus	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.96% 1/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Gastroenteritis salmonella	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.95% 1/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Infection	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	1.9% 2/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Lower respiratory tract infection viral	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.95% 1/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Meningitis viral	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.95% 1/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Neonatal bacterial pneumonia	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.95% 1/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Neonatal infection	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.96% 1/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Neonatal pneumonia	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.96% 1/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Pharyngitis	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.95% 1/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Pneumonia streptococcal	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.96% 1/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Pneumonia viral	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.96% 1/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Respiratory syncytial virus bronchiolitis	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	1.9% 2/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Respiratory syncytial virus infection	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.96% 1/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Upper respiratory tract infection	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.96% 1/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Nervous system disorders Unresponsive to stimuli	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.96% 1/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.

Other adverse events

Other adverse events
Measure	Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) n=22 participants at risk Nonpregnant participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) n=22 participants at risk Nonpregnant participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 1: Placebo (Nonpregnant) n=22 participants at risk Non pregnant participants were randomized to receive placebo (saline control) intramuscularly on Day 1.	Stage 1 Booster: GBS6 20 mcg With AlPO4 (Nonpregnant) n=11 participants at risk Non pregnant participants were randomized to receive a booster dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly at least 2 years after Vaccination 1 on Day 1. Participants were categorized based on their primary dose of GBS6 vaccine with AlPO4.	Stage 1 Booster: GBS6 20 mcg Without AlPO4 (Nonpregnant) n=7 participants at risk Non pregnant participants were randomized to receive a booster dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly at least 2 years after Vaccination 1 on Day 1. Participants were categorized based on their primary dose of GBS6 vaccine without AlPO4.	Stage 1 Booster: Placebo (Nonpregnant) n=8 participants at risk Non pregnant participants were randomized to receive a booster dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly at least 2 years after Vaccination 1 on Day 1. Participants were categorized based on their primary dose of Placebo.	Stage 2: GBS6 5 mcg With AlPO4 (Maternal) n=40 participants at risk Maternal participants were randomized to receive a single dose of 5 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 5 mcg Without AlPO4 (Maternal) n=40 participants at risk Maternal participants were randomized to receive a single dose of 5 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 10 mcg With AlPO4 (Maternal) n=40 participants at risk Maternal participants were randomized to receive a single dose of 10 μg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) n=40 participants at risk Maternal participants were randomized to receive a single dose of 10 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg With AlPO4 (Maternal) n=40 participants at risk Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) n=40 participants at risk Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: Placebo (Maternal) n=120 participants at risk Maternal participants were randomized to receive placebo (saline control) intramuscularly on Day 1.	Stage 2: GBS6 5 mcg With AlPO4 (Infant) n=40 participants at risk Infant participants born to the maternal participants randomized to receive a single dose of 5 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 5 mcg Without AlPO4 (Infant) n=39 participants at risk Infant participants born to the maternal participants randomized to receive a single dose of 5 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 10 mcg With AlPO4 (Infant) n=40 participants at risk Infant participants born to the maternal participants randomized to receive a single dose of 10 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 10 mcg Without AlPO4 (Infant) n=40 participants at risk Infant participants born to the maternal participants randomized to receive a single dose of 10 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg With AlPO4 (Infant) n=40 participants at risk Infant participants born to the maternal participants randomized to receive a single dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.	Stage 2: GBS6 20 mcg Without AlPO4 (Infant) n=40 participants at risk Infant participants born to the maternal participants randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 2: Placebo (Infant) n=118 participants at risk Infant participants born to the maternal participants randomized to receive placebo (saline control) intramuscularly on Day 1.	Stage 3: GBS6 20 mcg Without AlPO4 (Maternal) n=108 participants at risk Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 3: Placebo (Maternal) n=108 participants at risk Maternal participants were randomized to receive placebo (saline control) intramuscularly on Day 1	Stage 3: GBS6 20 mcg Without AlPO4 (Infant) n=104 participants at risk Infant participants born to the maternal participants randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.	Stage 3: Placebo (Infant) n=105 participants at risk Infant participants born to the maternal participants randomized to receive placebo (saline control) intramuscularly on Day 1.
Pregnancy, puerperium and perinatal conditions Premature delivery	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	30.0% 12/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Pregnancy, puerperium and perinatal conditions Premature labour	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Pregnancy, puerperium and perinatal conditions Retained placenta or membranes	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.83% 1/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Renal and urinary disorders Leukocyturia	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.8% 3/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Psychiatric disorders Perinatal depression	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Psychiatric disorders Stress	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Renal and urinary disorders Glycosuria	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.83% 1/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Gastrointestinal disorders Abdominal pain lower	4.5% 1/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	9.1% 1/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 3/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Ear and labyrinth disorders Ear pain	4.5% 1/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	9.1% 1/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Gastrointestinal disorders Diarrhoea	4.5% 1/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	1.7% 2/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.6% 1/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	5.0% 2/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 3/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	1.9% 2/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.95% 1/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Gastrointestinal disorders Diarrhoea (DIARRHEA)	18.2% 4/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	9.1% 2/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	18.2% 4/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	18.2% 2/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	25.0% 2/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	5.0% 2/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	17.5% 7/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	10.0% 4/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	22.5% 9/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	7.5% 3/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	10.0% 4/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	16.7% 20/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	12.0% 13/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	11.1% 12/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Gastrointestinal disorders Dyspepsia	4.5% 1/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	9.1% 1/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	5.0% 2/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	1.9% 2/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Gastrointestinal disorders Gastritis	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	4.5% 1/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	12.5% 1/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.85% 1/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.9% 3/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	3.8% 4/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	4.5% 1/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	7.5% 3/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	5.0% 2/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	5.0% 2/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.83% 1/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Nervous system disorders Headache (HEADACHE)	40.9% 9/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	40.9% 9/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	54.5% 12/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	45.5% 5/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	28.6% 2/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	75.0% 6/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	30.0% 12/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	47.5% 19/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	30.0% 12/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	32.5% 13/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	32.5% 13/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	40.0% 16/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	33.3% 40/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	36.1% 39/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	36.1% 39/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Gastrointestinal disorders Vomiting (NAUSEA/VOMITING)	9.1% 2/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	13.6% 3/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	31.8% 7/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	9.1% 1/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	14.3% 1/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	62.5% 5/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	15.0% 6/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	7.5% 3/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	20.0% 8/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	15.0% 6/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	15.0% 6/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	22.5% 9/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	26.7% 32/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	21.3% 23/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	27.8% 30/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
General disorders Fatigue (FATIGUE)	36.4% 8/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	31.8% 7/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	45.5% 10/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	36.4% 4/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	14.3% 1/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	62.5% 5/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	37.5% 15/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	45.0% 18/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	37.5% 15/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	37.5% 15/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	47.5% 19/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	42.5% 17/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	40.0% 48/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	41.7% 45/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	40.7% 44/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
General disorders Injection site discolouration	4.5% 1/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	4.5% 1/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	9.1% 1/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	14.3% 1/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
General disorders Injection site erythema (REDNESS)	18.2% 4/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	4.5% 1/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	4.5% 1/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	18.2% 2/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	14.3% 1/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	12.5% 1/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	1.7% 2/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Immune system disorders Seasonal allergy	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
General disorders Injection site pain (PAIN)	40.9% 9/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	36.4% 8/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	31.8% 7/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	81.8% 9/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	42.9% 3/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	50.0% 4/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	37.5% 15/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	15.0% 6/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	40.0% 16/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	15.0% 6/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	47.5% 19/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	35.0% 14/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	15.8% 19/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	29.6% 32/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	17.6% 19/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
General disorders Injection site pruritus	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	4.5% 1/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	14.3% 1/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	5.0% 2/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
General disorders Injection site swelling (SWELLING)	13.6% 3/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	9.1% 2/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	27.3% 3/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	14.3% 1/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	5.0% 2/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.83% 1/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
General disorders Oedema peripheral	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	4.5% 1/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	14.3% 1/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
General disorders Pyrexia (FEVER)	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	4.5% 1/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	5.0% 2/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	7.5% 3/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	5.0% 2/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	5.0% 6/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.8% 3/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	3.7% 4/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
General disorders Swelling	4.5% 1/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	9.1% 1/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Abscess bacterial	4.5% 1/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	4.5% 1/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	4.5% 1/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	9.1% 1/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	14.3% 1/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.85% 1/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Gastroenteritis	4.5% 1/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	5.0% 2/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.83% 1/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	7.5% 3/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	7.5% 3/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	3.4% 4/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	3.8% 4/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Sinusitis	4.5% 1/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	9.1% 1/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Tonsillitis	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	4.5% 1/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	12.5% 1/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	1.9% 2/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Tonsillitis bacterial	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	4.5% 1/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Upper respiratory tract infection	18.2% 4/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	4.5% 1/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	9.1% 2/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	18.2% 2/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	14.3% 1/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	7.5% 3/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	5.0% 2/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	5.0% 2/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	7.5% 3/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	5.0% 2/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	5.0% 2/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	4.2% 5/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	22.5% 9/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	7.7% 3/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	12.5% 5/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	17.5% 7/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	27.5% 11/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	27.5% 11/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	17.8% 21/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	35.2% 38/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	28.7% 31/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Urinary tract infection	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	7.4% 8/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	8.3% 9/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Vaginal infection	4.5% 1/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	9.1% 1/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.83% 1/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Viral rhinitis	9.1% 2/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	4.5% 1/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	9.1% 1/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.6% 1/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Viral upper respiratory tract infection	4.5% 1/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Vulval abscess	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	4.5% 1/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	14.3% 1/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.83% 1/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Injury, poisoning and procedural complications Exposure during pregnancy	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	4.5% 1/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	4.5% 1/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	14.3% 1/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	12.5% 1/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Musculoskeletal and connective tissue disorders Myalgia (MUSCLE PAIN)	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	12.5% 5/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	25.0% 10/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	17.5% 7/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	15.0% 6/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	17.5% 7/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	25.0% 10/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	15.8% 19/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Nervous system disorders Headache	4.5% 1/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	22.7% 5/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	4.5% 1/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	9.1% 1/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	14.3% 1/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	12.5% 1/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	5.0% 2/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 3/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.8% 3/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Psychiatric disorders Depression	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	4.5% 1/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	14.3% 1/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Reproductive system and breast disorders Dysmenorrhoea	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	4.5% 1/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Reproductive system and breast disorders Vaginal haemorrhage	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	4.5% 1/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	12.5% 1/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.83% 1/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	4.5% 1/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	12.5% 1/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	17.5% 7/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	10.3% 4/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	5.0% 2/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	12.5% 5/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	5.0% 2/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	5.0% 2/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	5.9% 7/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Respiratory, thoracic and mediastinal disorders Sneezing	4.5% 1/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	9.1% 1/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	4.5% 1/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	14.3% 1/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	5.1% 2/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.85% 1/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.96% 1/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.95% 1/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	4.5% 1/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Vascular disorders Hypertension	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	4.5% 1/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	14.3% 1/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	5.0% 2/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	10.0% 4/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	5.0% 2/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 3/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	1.9% 2/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Blood and lymphatic system disorders Anaemia	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	4.6% 5/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.95% 1/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Cardiac disorders Tachycardia	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	1.9% 2/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Eye disorders Vision blurred	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.83% 1/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Eye disorders Visual impairment	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.83% 1/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Gastrointestinal disorders Abdominal pain	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.85% 1/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Gastrointestinal disorders Constipation	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	3.3% 4/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	5.0% 2/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.6% 1/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	5.0% 2/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	5.0% 2/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 3/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	1.9% 2/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.9% 3/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Gastrointestinal disorders Haemorrhoids	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.83% 1/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Gastrointestinal disorders Nausea	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Gastrointestinal disorders Toothache	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Gastrointestinal disorders Vomiting	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.85% 1/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.96% 1/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
General disorders Influenza like illness	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	5.0% 2/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.95% 1/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
General disorders Oedema	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.83% 1/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
General disorders Pyrexia	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.83% 1/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.85% 1/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	1.9% 2/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	1.9% 2/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Abscess limb	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.83% 1/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Bartholin's abscess	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.83% 1/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Breast abscess	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.83% 1/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Conjunctivitis	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Escherichia urinary tract infection	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.83% 1/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Gingivitis	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.83% 1/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Mastitis	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	1.9% 2/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	3.7% 4/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Sexually transmitted disease	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.83% 1/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Subcutaneous abscess	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.85% 1/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.96% 1/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Vulvovaginitis	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.83% 1/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Wound sepsis	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Injury, poisoning and procedural complications Exposure to communicable disease	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.83% 1/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Injury, poisoning and procedural complications Fall	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Injury, poisoning and procedural complications Incision site pain	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Injury, poisoning and procedural complications Incision site rash	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Pregnancy, puerperium and perinatal conditions Gestational hypertension	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	3.7% 4/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Injury, poisoning and procedural complications Perineal injury	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	4.2% 5/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	7.4% 8/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Injury, poisoning and procedural complications Vulvovaginal injury	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	1.7% 2/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	1.9% 2/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Investigations Amniotic fluid index decreased	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Investigations Aspartate aminotransferase increased	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.83% 1/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Investigations White blood cell count increased	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Musculoskeletal and connective tissue disorders Arthralgia (JOINT PAIN)	13.6% 3/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	22.7% 5/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	9.1% 2/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	18.2% 2/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	14.3% 1/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	25.0% 2/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	10.0% 4/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	10.0% 4/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	12.5% 5/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	15.0% 6/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	20.0% 8/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	16.7% 20/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	14.8% 16/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	13.0% 14/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Musculoskeletal and connective tissue disorders Tenosynovitis stenosans	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.83% 1/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Anogenital warts	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin papilloma	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Nervous system disorders Sciatica	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Pregnancy, puerperium and perinatal conditions Breech delivery	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.83% 1/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Pregnancy, puerperium and perinatal conditions Failed induction of labour	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.83% 1/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Pregnancy, puerperium and perinatal conditions False labour	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	1.7% 2/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Pregnancy, puerperium and perinatal conditions Foetal growth restriction	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Pregnancy, puerperium and perinatal conditions Hyperemesis gravidarum	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Pregnancy, puerperium and perinatal conditions Morning sickness	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Pregnancy, puerperium and perinatal conditions Postpartum haemorrhage	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	1.9% 2/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Renal and urinary disorders Proteinuria	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	1.9% 2/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Reproductive system and breast disorders Breast engorgement	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.83% 1/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Reproductive system and breast disorders Uterine prolapse	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.83% 1/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Reproductive system and breast disorders Vaginal discharge	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Reproductive system and breast disorders Vaginal disorder	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Reproductive system and breast disorders Vaginal haematoma	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.83% 1/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.83% 1/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Skin and subcutaneous tissue disorders Eczema	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	1.7% 2/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	12.5% 5/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	5.1% 2/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	5.0% 2/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	7.5% 3/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	5.0% 2/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	5.1% 6/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	7.4% 8/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	10.2% 11/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	7.7% 8/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	10.5% 11/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Skin and subcutaneous tissue disorders Hidradenitis	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Surgical and medical procedures Suture insertion	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Vascular disorders Hypotension	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Vascular disorders Inferior vena cava syndrome	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.83% 1/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.96% 1/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.95% 1/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Blood and lymphatic system disorders Microcytic anaemia	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Ear and labyrinth disorders Otorrhoea	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.6% 1/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Eye disorders Strabismus	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Gastrointestinal disorders Anal fissure	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.85% 1/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
General disorders Ill-defined disorder	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.85% 1/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
General disorders Macrosomia	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.95% 1/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
General disorders Vaccination site erythema	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
General disorders Vaccination site induration	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Pregnancy, puerperium and perinatal conditions Gestational diabetes	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Pregnancy, puerperium and perinatal conditions Haemorrhage in pregnancy	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Pregnancy, puerperium and perinatal conditions Jaundice neonatal	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	7.5% 3/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	3.4% 4/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Pregnancy, puerperium and perinatal conditions Low birth weight baby	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	5.0% 2/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.6% 1/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.85% 1/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Pregnancy, puerperium and perinatal conditions Meconium stain	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.6% 1/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Pregnancy, puerperium and perinatal conditions Pelvic haematoma obstetric	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Pregnancy, puerperium and perinatal conditions Premature baby	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	5.0% 2/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.6% 1/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	1.7% 2/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Pregnancy, puerperium and perinatal conditions Premature rupture of membranes	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Pregnancy, puerperium and perinatal conditions Prolonged labour	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	1.9% 2/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Pregnancy, puerperium and perinatal conditions Prolonged pregnancy	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Pregnancy, puerperium and perinatal conditions Prolonged rupture of membranes	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Pregnancy, puerperium and perinatal conditions Shoulder dystocia	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Abscess	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Candida nappy rash	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	5.0% 2/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Conjunctivitis viral	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Folliculitis	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations HIV infection	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Impetigo	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	5.0% 2/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Lower respiratory tract infection	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 3/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	6.5% 7/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	3.7% 4/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Lower respiratory tract infection viral	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.85% 1/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Nasopharyngitis	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Omphalitis	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Ophthalmia neonatorum	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	1.9% 2/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	1.9% 2/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Oral candidiasis	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	5.0% 2/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.6% 1/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	7.5% 3/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	7.5% 3/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	8.3% 9/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	11.1% 12/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Otitis media	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Otitis media acute	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	1.7% 2/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	1.9% 2/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Pharyngitis	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Pneumonia viral	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.6% 1/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Pulmonary tuberculosis	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Rash pustular	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.6% 1/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Rhinitis	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	1.7% 2/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.8% 3/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Skin candida	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Tinea infection	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Vaccination site abscess	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.85% 1/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Varicella	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.85% 1/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Varicella zoster virus infection	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Injury, poisoning and procedural complications Brachial plexus injury	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.85% 1/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Injury, poisoning and procedural complications Joint injury	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Musculoskeletal and connective tissue disorders Bone swelling	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.6% 1/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Nervous system disorders Febrile convulsion	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Pregnancy, puerperium and perinatal conditions Caput succedaneum	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.85% 1/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Pregnancy, puerperium and perinatal conditions Small for dates baby	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	7.5% 3/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.6% 1/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	1.7% 2/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	3.7% 4/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Reproductive system and breast disorders Balanoposthitis	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Skin and subcutaneous tissue disorders Dermatitis contact	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.96% 1/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Skin and subcutaneous tissue disorders Dermatitis diaper	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	12.5% 5/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	5.0% 2/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	5.0% 2/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	1.7% 2/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	11.1% 12/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	9.3% 10/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	11.5% 12/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	9.5% 10/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Skin and subcutaneous tissue disorders Miliaria	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	8.3% 9/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	7.4% 8/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	8.7% 9/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	7.6% 8/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Skin and subcutaneous tissue disorders Perioral dermatitis	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.96% 1/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Skin and subcutaneous tissue disorders Rash papular	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.6% 1/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	5.0% 2/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	1.7% 2/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	1.9% 2/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.9% 3/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	1.9% 2/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Blood and lymphatic system disorders Neutropenia	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.96% 1/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.95% 1/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Cardiac disorders Bradycardia neonatal	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.95% 1/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Congenital, familial and genetic disorders Atrial septal defect	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.96% 1/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Congenital, familial and genetic disorders Dacryostenosis congenital	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.95% 1/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Congenital, familial and genetic disorders Hydrocele	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.95% 1/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Congenital, familial and genetic disorders Patent ductus arteriosus	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	1.9% 2/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Congenital, familial and genetic disorders Tethered oral tissue	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	1.9% 2/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.9% 3/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Eye disorders Dacryostenosis acquired	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.96% 1/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Eye disorders Retinopathy of prematurity	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.95% 1/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Gastrointestinal disorders Flatulence	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.95% 1/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Gastrointestinal disorders Infantile colic	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.96% 1/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Gastrointestinal disorders Mouth ulceration	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.96% 1/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Gastrointestinal disorders Stomatitis	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.96% 1/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.96% 1/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Hepatobiliary disorders Hyperbilirubinaemia neonatal	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	1.9% 2/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	4.8% 5/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Immune system disorders Drug hypersensitivity	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.95% 1/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Immune system disorders Food allergy	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.96% 1/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.95% 1/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Immune system disorders Milk allergy	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.96% 1/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.95% 1/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Acarodermatitis	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.95% 1/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Body tinea	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	12.5% 1/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	1.7% 2/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	1.9% 2/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	1.9% 2/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.9% 3/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Bronchitis	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.96% 1/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.95% 1/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Bronchiolitis	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	5.1% 2/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	5.0% 2/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	7.5% 3/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	3.4% 4/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	4.8% 5/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	1.9% 2/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations COVID-19	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.8% 3/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Candida infection	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.85% 1/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	1.9% 2/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	1.9% 2/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.95% 1/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Cellulitis	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.96% 1/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Chronic sinusitis	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.95% 1/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Conjunctivitis bacteria	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.9% 3/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.95% 1/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Dysentery	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.85% 1/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.95% 1/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Eczema infected	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.95% 1/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Fungal infection	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Fungal skin infection	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Furuncle	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	1.9% 2/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Oral herpes	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Otitis media chronic	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Parvovirus infection	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Pneumonia	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.8% 3/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Respiratory syncytial virus bronchiolitis	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Respiratory syncytial virus infection	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Respiratory tract infection viral	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Vulvovaginal candidiasis	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Injury, poisoning and procedural complications Arthropod bite	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Cardiac murmur	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Investigations Weight decreased	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Metabolism and nutrition disorders Feeding disorder	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Metabolic acidosis	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Obesity	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Weight gain poor	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Musculoskeletal and connective tissue disorders Acquired plagiocephaly	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Newborn head moulding	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Pain in extremity	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Cephalhaematoma	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Jaundice neonatal	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	7.4% 8/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.8% 3/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Low birth weight baby	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.8% 3/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.8% 3/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Meconium stain	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Premature baby	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	3.7% 4/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	1.9% 2/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Shoulder dystocia	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Reproductive system and breast disorders Penile adhesion	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.96% 1/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Respiratory, thoracic and mediastinal disorders Adenoidal hypertrophy	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.96% 1/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Respiratory, thoracic and mediastinal disorders Neonatal respiratory distress	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.95% 1/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Respiratory, thoracic and mediastinal disorders Transient tachypnoea of the newborn	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.6% 1/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.95% 1/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Skin and subcutaneous tissue disorders Dermatitis atopic	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.96% 1/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.95% 1/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.96% 1/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.95% 1/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Skin and subcutaneous tissue disorders Eczema infantile	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	1.9% 2/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	1.9% 2/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Skin and subcutaneous tissue disorders Macule	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.96% 1/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Skin and subcutaneous tissue disorders Milia	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	1.9% 2/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	1.9% 2/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	1.9% 2/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	1.9% 2/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Skin and subcutaneous tissue disorders Rash	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.83% 1/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	7.5% 3/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	4.6% 5/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	1.9% 2/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	4.8% 5/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	1.9% 2/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Skin and subcutaneous tissue disorders Rash macular	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	1.9% 2/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	1.9% 2/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Eye disorders Conjunctivitis allergic	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Skin and subcutaneous tissue disorders Seborrhoeic dermatitis	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.85% 1/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	3.7% 4/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	1.9% 2/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	3.8% 4/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	1.9% 2/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Skin and subcutaneous tissue disorders Transient neonatal pustular melanosis	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.96% 1/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.96% 1/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Blood and lymphatic system disorders Anaemia of pregnancy	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Blood and lymphatic system disorders Blood loss anaemia	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Cardiac disorders Palpitations	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	3.7% 4/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Cardiac disorders Tachycardia foetal	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Gastrointestinal disorders Dental caries	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	1.9% 2/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Gastrointestinal disorders Umbilical hernia	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Gastrointestinal disorders Haemorrhoidal haemorrhage	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Gastrointestinal disorders Haemorrhoids thrombosed	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Gastrointestinal disorders Intra-abdominal fluid collection	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Bacterial vaginosis	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.83% 1/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	1.9% 2/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Viral pharyngitis	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Chlamydial infection	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Cystitis	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Eczema impetiginous	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Endometritis	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Hand-foot-and-mouth disease	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Influenza	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	1.9% 2/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Musculoskeletal and connective tissue disorders Ligament pain	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	1.9% 2/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Norovirus infection	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Otitis externa	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Pharyngitis streptococcal	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Postoperative wound infection	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	1.9% 2/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Infections and infestations Respiratory tract infection	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Injury, poisoning and procedural complications Animal bite	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Injury, poisoning and procedural complications Procedural pain	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.8% 3/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Investigations SARS-CoV-2 test positive	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Nervous system disorders Carpal tunnel syndrome	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Nervous system disorders Dizziness	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	1.7% 2/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	1.9% 2/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Nervous system disorders Tension headache	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	2.5% 1/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Pregnancy, puerperium and perinatal conditions Cephalo-pelvic disproportion	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Nervous system disorders Neurodevelopmental delay	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.85% 1/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Renal and urinary disorders Acute kidney injury	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.85% 1/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Reproductive system and breast disorders Breast pain	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Reproductive system and breast disorders Genital labial adhesions	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Surgical and medical procedures Episiotomy	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Vascular disorders Phlebitis	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Vascular disorders Raynaud's phenomenon	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/22 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/11 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/7 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/8 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/120 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/39 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/40 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/118 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.93% 1/108 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/104 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.	0.00% 0/105 • For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery Same event may appear as non-SAE \& SAE but are distinct events. Event may be serious in one participant \& non-serious in another or one participant may have experienced both serious \& non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publication until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Publication restrictions are in place

Restriction type: OTHER