Trial Outcomes & Findings for A Phase 1/2, Randomized, Placebo-controlled, Observer-blinded Trial To Evaluate The Safety, Tolerability, And Immunogenicity Of A Multivalent Group B Streptococcus Vaccine In Healthy Adults 18 To 49 Years Of Age (NCT NCT03170609)

Last Updated: 2019-07-02

Results Overview

Hemoglobin:Grade(G)1: 11-13.5g/dL, G2:9.5-12.4g/dL,G3:8-10.4 g/dL, G4:\<8.0 g/dL; leukocyte increase:G1: 10.8-15\*10\^9/Liter\[L\],G2:\>15-20\*10\^9/L, G3:\>20-25\*10\^9/L, G4:\>25\*10\^9/L,leukocyte decrease: G1: 2.5-3.5\*10\^9/L, G2: 1.5-\<2.5\*10\^9/L, G3: 1-\<1.5\*10\^9/L, G4:\<1\*10\^9/L; neutrophil decrease:G1: 1.5-2\*10\^9/L, G2:1-\<1.5\*10\^9/L, G3:0.5-\<1\*10\^9/L,G4:\<0.5\*10\^9/L; platelets:G1: 125-140\*10\^9/L, G2:100-124\*10\^9/L, G3:25-99\*10\^9/L, G4:\<25\*10\^9/L; eosinophils: G1: 0.65-1.5\*10\^9/L, G2:\>1.5-5\*10\^9/L, G3:\>5\*10\^9/L, G4: hypereosinophilic;alanine aminotransferase,aspartate aminotransferase:G1: 1.1-2.5 \*ULN, G2:2.6-5.0\*ULN, G3:5.1-10\*ULN, G4:\>10\*ULN; alkaline phosphatase:G1: 1.1-2\*ULN, G2:2.1-3\*ULN, G3:3.1-10\*ULN, G4:\>10\*ULN; Bilirubin:G1: 1.1-1.5\*ULN, G2: 1.26-2\*ULN,G3: 1.51-3.0\*ULN,G4:\>1.75\*ULN;blood urea nitrogen:G1:23-26mg/dL,G2:27-31mg/dL,G3:\>31mg/dL, G4:dialysis;creatinine:G1:1.5-1.7mg/dL,G2:1.8-2mg/dL,G3:2.1-2.5 mg/dL,G4:dialysis.Categories with\>=1 participant with abnormality are reported only.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

365 participants

Primary outcome timeframe

1 week after vaccination

Results posted on

2019-07-02

Participant Flow

Participant milestones

Participant milestones
Measure	GBS6 5 Microgram With Aluminum Phosphate Participants were randomized to receive a single dose of 5 microgram of Group B Streptococcus 6-valent (GBS6) vaccine with aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.	GBS6 5 Microgram Without Aluminum Phosphate Participants were randomized to receive a single dose of 5 microgram of GBS6 vaccine without aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.	GBS6 10 Microgram With Aluminum Phosphate Participants were randomized to receive a single dose of 10 microgram of GBS6 vaccine with aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.	GBS6 10 Microgram Without Aluminum Phosphate Participants were randomized to receive a single dose of 10 microgram of GBS6 vaccine without aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.	GBS6 20 Microgram With Aluminum Phosphate Participants were randomized to receive a single dose of 20 microgram of GBS6 vaccine with aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.	GBS6 20 Microgram Without Aluminum Phosphate Participants were randomized to receive a single dose of 20 microgram of GBS6 vaccine without aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.	Placebo Participants were randomized to receive placebo (saline control) intramuscularly on Day 1 and were followed up to 6 months.
Overall Study STARTED	53	52	52	52	52	52	52
Overall Study Vaccinated	52	52	52	52	52	52	52
Overall Study COMPLETED	50	50	46	50	51	50	51
Overall Study NOT COMPLETED	3	2	6	2	1	2	1

Reasons for withdrawal

Reasons for withdrawal
Measure	GBS6 5 Microgram With Aluminum Phosphate Participants were randomized to receive a single dose of 5 microgram of Group B Streptococcus 6-valent (GBS6) vaccine with aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.	GBS6 5 Microgram Without Aluminum Phosphate Participants were randomized to receive a single dose of 5 microgram of GBS6 vaccine without aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.	GBS6 10 Microgram With Aluminum Phosphate Participants were randomized to receive a single dose of 10 microgram of GBS6 vaccine with aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.	GBS6 10 Microgram Without Aluminum Phosphate Participants were randomized to receive a single dose of 10 microgram of GBS6 vaccine without aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.	GBS6 20 Microgram With Aluminum Phosphate Participants were randomized to receive a single dose of 20 microgram of GBS6 vaccine with aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.	GBS6 20 Microgram Without Aluminum Phosphate Participants were randomized to receive a single dose of 20 microgram of GBS6 vaccine without aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.	Placebo Participants were randomized to receive placebo (saline control) intramuscularly on Day 1 and were followed up to 6 months.
Overall Study Death	0	0	1	0	0	0	0
Overall Study Withdrawal by Subject	1	2	0	0	0	0	1
Overall Study Lost to Follow-up	1	0	5	2	1	1	0
Overall Study Other	1	0	0	0	0	1	0

Baseline Characteristics

A Phase 1/2, Randomized, Placebo-controlled, Observer-blinded Trial To Evaluate The Safety, Tolerability, And Immunogenicity Of A Multivalent Group B Streptococcus Vaccine In Healthy Adults 18 To 49 Years Of Age

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	GBS6 5 Microgram With Aluminum Phosphate n=52 Participants Participants were randomized to receive a single dose of 5 microgram of GBS6 vaccine with aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.	GBS6 5 Microgram Without Aluminum Phosphate n=52 Participants Participants were randomized to receive a single dose of 5 microgram of GBS6 vaccine without aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.	GBS6 10 Microgram With Aluminum Phosphate n=52 Participants Participants were randomized to receive a single dose of 10 microgram of GBS6 vaccine with aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.	GBS6 10 Microgram Without Aluminum Phosphate n=52 Participants Participants were randomized to receive a single dose of 10 microgram of GBS6 vaccine without aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.	GBS6 20 Microgram With Aluminum Phosphate n=52 Participants Participants were randomized to receive a single dose of 20 microgram of GBS6 vaccine with aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months	GBS6 20 Microgram Without Aluminum Phosphate n=52 Participants Participants were randomized to receive a single dose of 20 microgram of GBS6 vaccine without aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.	Placebo n=52 Participants Participants were randomized to receive placebo (saline control) intramuscularly on Day 1 and were followed up to 6 months.	Total n=364 Participants Total of all reporting groups
Race/Ethnicity, Customized Black or African American	5 Participants n=5 Participants	9 Participants n=7 Participants	5 Participants n=5 Participants	8 Participants n=4 Participants	4 Participants n=21 Participants	4 Participants n=10 Participants	7 Participants n=115 Participants	42 Participants n=24 Participants
Race/Ethnicity, Customized Other	2 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	2 Participants n=21 Participants	2 Participants n=10 Participants	0 Participants n=115 Participants	9 Participants n=24 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants	5 Participants n=24 Participants
Age, Continuous	32.9 years STANDARD_DEVIATION 8.43 • n=5 Participants	34.7 years STANDARD_DEVIATION 9.35 • n=7 Participants	32.8 years STANDARD_DEVIATION 8.31 • n=5 Participants	31.9 years STANDARD_DEVIATION 8.10 • n=4 Participants	33.2 years STANDARD_DEVIATION 8.67 • n=21 Participants	30.5 years STANDARD_DEVIATION 8.25 • n=10 Participants	32.8 years STANDARD_DEVIATION 8.74 • n=115 Participants	32.7 years STANDARD_DEVIATION 8.57 • n=24 Participants
Sex: Female, Male Female	35 Participants n=5 Participants	41 Participants n=7 Participants	32 Participants n=5 Participants	33 Participants n=4 Participants	35 Participants n=21 Participants	37 Participants n=10 Participants	43 Participants n=115 Participants	256 Participants n=24 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	11 Participants n=7 Participants	20 Participants n=5 Participants	19 Participants n=4 Participants	17 Participants n=21 Participants	15 Participants n=10 Participants	9 Participants n=115 Participants	108 Participants n=24 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	4 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	5 Participants n=21 Participants	1 Participants n=10 Participants	5 Participants n=115 Participants	21 Participants n=24 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	50 Participants n=5 Participants	47 Participants n=7 Participants	50 Participants n=5 Participants	49 Participants n=4 Participants	47 Participants n=21 Participants	51 Participants n=10 Participants	47 Participants n=115 Participants	341 Participants n=24 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	2 Participants n=24 Participants
Race/Ethnicity, Customized White	44 Participants n=5 Participants	41 Participants n=7 Participants	46 Participants n=5 Participants	41 Participants n=4 Participants	45 Participants n=21 Participants	46 Participants n=10 Participants	44 Participants n=115 Participants	307 Participants n=24 Participants
Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander	0 Participants n=5 Participants	1 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	1 Participants n=24 Participants

PRIMARY outcome

Timeframe: 1 week after vaccination

Population: Analysis population for this outcome measure included a subset of participants who received GBS6 vaccine or placebo.

Outcome measures

Outcome measures
Measure	GBS6 5 Microgram With Aluminum Phosphate n=16 Participants Participants were randomized to receive a single dose of 5 microgram of GBS6 vaccine with aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.	GBS6 5 Microgram Without Aluminum Phosphate n=16 Participants Participants were randomized to receive a single dose of 5 microgram of GBS6 vaccine without aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.	GBS6 10 Microgram With Aluminum Phosphate n=16 Participants Participants were randomized to receive a single dose of 10 microgram of GBS6 vaccine with aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.	GBS6 10 Microgram Without Aluminum Phosphate n=16 Participants Participants were randomized to receive a single dose of 10 microgram of GBS6 vaccine without aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.	GBS6 20 Microgram With Aluminum Phosphate n=16 Participants Participants were randomized to receive a single dose of 20 microgram of GBS6 vaccine with aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months	GBS6 20 Microgram Without Aluminum Phosphate n=16 Participants Participants were randomized to receive a single dose of 20 microgram of GBS6 vaccine without aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.	Placebo n=24 Participants Participants were randomized to receive placebo (saline control) intramuscularly on Day 1 and were followed up to 6 months.
Percentage of Participants With Clinical Laboratory Abnormalities at 1-Week After Vaccination as Measured by Food and Drug Administration (FDA) Grade Alanine aminotransferase: Grade 1	0 percentage of participants	6.3 percentage of participants	0 percentage of participants	0 percentage of participants	12.5 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With Clinical Laboratory Abnormalities at 1-Week After Vaccination as Measured by Food and Drug Administration (FDA) Grade Bilirubin in presence of normal AST and ALT:Grade1	0 percentage of participants	0 percentage of participants	6.3 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With Clinical Laboratory Abnormalities at 1-Week After Vaccination as Measured by Food and Drug Administration (FDA) Grade Alkaline phosphate: Grade 1	0 percentage of participants	0 percentage of participants	6.3 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With Clinical Laboratory Abnormalities at 1-Week After Vaccination as Measured by Food and Drug Administration (FDA) Grade Hemoglobin: Grade 1	0 percentage of participants	6.3 percentage of participants	12.5 percentage of participants	0 percentage of participants	0 percentage of participants	6.3 percentage of participants	0 percentage of participants
Percentage of Participants With Clinical Laboratory Abnormalities at 1-Week After Vaccination as Measured by Food and Drug Administration (FDA) Grade Hemoglobin: Grade 2	6.3 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 Clinical Laboratory Abnormalities at 1-Week After Vaccination as Measured by Food and Drug Administration (FDA) Grade Platelets: Grade 1	0 percentage of participants	0 percentage of participants	6.3 percentage of participants	6.7 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With Clinical Laboratory Abnormalities at 1-Week After Vaccination as Measured by Food and Drug Administration (FDA) Grade Leukocyte decrease:Grade 1	6.3 percentage of participants	6.3 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 Clinical Laboratory Abnormalities at 1-Week After Vaccination as Measured by Food and Drug Administration (FDA) Grade Leukocyte increase: Grade 1	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	6.3 percentage of participants	0 percentage of participants
Percentage of Participants With Clinical Laboratory Abnormalities at 1-Week After Vaccination as Measured by Food and Drug Administration (FDA) Grade Leukocyte increase: 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	4.2 percentage of participants
Percentage of Participants With Clinical Laboratory Abnormalities at 1-Week After Vaccination as Measured by Food and Drug Administration (FDA) Grade Neutrophils decrease(Absolute): Grade 1	6.3 percentage of participants	18.8 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	6.3 percentage of participants	0 percentage of participants
Percentage of Participants With Clinical Laboratory Abnormalities at 1-Week After Vaccination as Measured by Food and Drug Administration (FDA) Grade Neutrophils decrease (Absolute): Grade 2	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	6.3 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With Clinical Laboratory Abnormalities at 1-Week After Vaccination as Measured by Food and Drug Administration (FDA) Grade Blood urea nitrogen: 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	4.2 percentage of participants
Percentage of Participants With Clinical Laboratory Abnormalities at 1-Week After Vaccination as Measured by Food and Drug Administration (FDA) Grade Blood urea nitrogen: Grade 2	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	6.3 percentage of participants	0 percentage of participants
Percentage of Participants With Clinical Laboratory Abnormalities at 1-Week After Vaccination as Measured by Food and Drug Administration (FDA) Grade Aspartate aminotransferase: Grade 1	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	6.3 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With Clinical Laboratory Abnormalities at 1-Week After Vaccination as Measured by Food and Drug Administration (FDA) Grade Aspartate aminotransferase: Grade 3	0 percentage of participants	6.3 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants

PRIMARY outcome

Timeframe: Within 14 days after vaccination

Population: Safety population included all participants who received GBS6 vaccine or placebo.

Local reactions were collected by using an e-diary and included redness, swelling and pain at injection site. Redness and swelling were graded as: mild (2.5-5.0 centimeter \[cm\]), moderate (greater than \[\>\] 5.0-10.0 cm) and severe (\>10.0 cm), grade 4 for redness (necrosis or exfoliative dermatitis) and grade 4 for swelling (necrosis). Pain at injection site was graded as: mild (did not interfere with activity), moderate (repeated use of nonnarcotic pain reliever \>24 hours or interfered with activity), severe (any use of narcotic pain reliever or prevented daily activity which resulted in missed days of work or school or was otherwise incapacitating, or included use of narcotics for analgesia), and grade 4 (required emergency room visit or hospitalization). The maximum severity (highest grading) of each location reaction within 14 days of vaccination was derived.

Outcome measures

Outcome measures
Measure	GBS6 5 Microgram With Aluminum Phosphate n=52 Participants Participants were randomized to receive a single dose of 5 microgram of GBS6 vaccine with aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.	GBS6 5 Microgram Without Aluminum Phosphate n=52 Participants Participants were randomized to receive a single dose of 5 microgram of GBS6 vaccine without aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.	GBS6 10 Microgram With Aluminum Phosphate n=52 Participants Participants were randomized to receive a single dose of 10 microgram of GBS6 vaccine with aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.	GBS6 10 Microgram Without Aluminum Phosphate n=52 Participants Participants were randomized to receive a single dose of 10 microgram of GBS6 vaccine without aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.	GBS6 20 Microgram With Aluminum Phosphate n=52 Participants Participants were randomized to receive a single dose of 20 microgram of GBS6 vaccine with aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months	GBS6 20 Microgram Without Aluminum Phosphate n=52 Participants Participants were randomized to receive a single dose of 20 microgram of GBS6 vaccine without aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.	Placebo n=52 Participants Participants were randomized to receive placebo (saline control) intramuscularly on Day 1 and were followed up to 6 months.
Percentage of Participants With Local Reactions by Maximum Severity Within 14 Days After Vaccination Swelling:Severe	0 percentage of participants Interval 0.0 to 6.8	0 percentage of participants Interval 0.0 to 6.8	0 percentage of participants Interval 0.0 to 6.8	0 percentage of participants Interval 0.0 to 6.8	0 percentage of participants Interval 0.0 to 6.8	0 percentage of participants Interval 0.0 to 6.8	0 percentage of participants Interval 0.0 to 6.8
Percentage of Participants With Local Reactions by Maximum Severity Within 14 Days After Vaccination Pain:Any	53.8 percentage of participants Interval 39.5 to 67.8	32.7 percentage of participants Interval 20.3 to 47.1	48.1 percentage of participants Interval 34.0 to 62.4	38.5 percentage of participants Interval 25.3 to 53.0	51.9 percentage of participants Interval 37.6 to 66.0	25.0 percentage of participants Interval 14.0 to 38.9	15.4 percentage of participants Interval 6.9 to 28.1
Percentage of Participants With Local Reactions by Maximum Severity Within 14 Days After Vaccination Pain:Mild	51.9 percentage of participants Interval 37.6 to 66.0	28.8 percentage of participants Interval 17.1 to 43.1	44.2 percentage of participants Interval 30.5 to 58.7	36.5 percentage of participants Interval 23.6 to 51.0	42.3 percentage of participants Interval 28.7 to 56.8	19.2 percentage of participants Interval 9.6 to 32.5	13.5 percentage of participants Interval 5.6 to 25.8
Percentage of Participants With Local Reactions by Maximum Severity Within 14 Days After Vaccination Pain:Moderate	1.9 percentage of participants Interval 0.0 to 10.3	3.8 percentage of participants Interval 0.5 to 13.2	3.8 percentage of participants Interval 0.5 to 13.2	1.9 percentage of participants Interval 0.0 to 10.3	9.6 percentage of participants Interval 3.2 to 21.0	5.8 percentage of participants Interval 1.2 to 15.9	1.9 percentage of participants Interval 0.0 to 10.3
Percentage of Participants With Local Reactions by Maximum Severity Within 14 Days After Vaccination Pain:Severe	0 percentage of participants Interval 0.0 to 6.8	0 percentage of participants Interval 0.0 to 6.8	0 percentage of participants Interval 0.0 to 6.8	0 percentage of participants Interval 0.0 to 6.8	0 percentage of participants Interval 0.0 to 6.8	0 percentage of participants Interval 0.0 to 6.8	0 percentage of participants Interval 0.0 to 6.8
Percentage of Participants With Local Reactions by Maximum Severity Within 14 Days After Vaccination Pain:Grade 4	0 percentage of participants Interval 0.0 to 6.8	0 percentage of participants Interval 0.0 to 6.8	0 percentage of participants Interval 0.0 to 6.8	0 percentage of participants Interval 0.0 to 6.8	0 percentage of participants Interval 0.0 to 6.8	0 percentage of participants Interval 0.0 to 6.8	0 percentage of participants Interval 0.0 to 6.8
Percentage of Participants With Local Reactions by Maximum Severity Within 14 Days After Vaccination Redness:Any	0 percentage of participants Interval 0.0 to 6.8	3.8 percentage of participants Interval 0.5 to 13.2	1.9 percentage of participants Interval 0.0 to 10.3	0 percentage of participants Interval 0.0 to 6.8	5.8 percentage of participants Interval 1.2 to 15.9	0 percentage of participants Interval 0.0 to 6.8	0 percentage of participants Interval 0.0 to 6.8
Percentage of Participants With Local Reactions by Maximum Severity Within 14 Days After Vaccination Redness:Mild	0 percentage of participants Interval 0.0 to 6.8	0 percentage of participants Interval 0.0 to 6.8	0 percentage of participants Interval 0.0 to 6.8	0 percentage of participants Interval 0.0 to 6.8	5.8 percentage of participants Interval 1.2 to 15.9	0 percentage of participants Interval 0.0 to 6.8	0 percentage of participants Interval 0.0 to 6.8
Percentage of Participants With Local Reactions by Maximum Severity Within 14 Days After Vaccination Redness:Moderate	0 percentage of participants Interval 0.0 to 6.8	3.8 percentage of participants Interval 0.5 to 13.2	1.9 percentage of participants Interval 0.0 to 10.3	0 percentage of participants Interval 0.0 to 6.8	0 percentage of participants Interval 0.0 to 6.8	0 percentage of participants Interval 0.0 to 6.8	0 percentage of participants Interval 0.0 to 6.8
Percentage of Participants With Local Reactions by Maximum Severity Within 14 Days After Vaccination Redness:Severe	0 percentage of participants Interval 0.0 to 6.8	0 percentage of participants Interval 0.0 to 6.8	0 percentage of participants Interval 0.0 to 6.8	0 percentage of participants Interval 0.0 to 6.8	0 percentage of participants Interval 0.0 to 6.8	0 percentage of participants Interval 0.0 to 6.8	0 percentage of participants Interval 0.0 to 6.8
Percentage of Participants With Local Reactions by Maximum Severity Within 14 Days After Vaccination Redness:Grade 4	0 percentage of participants Interval 0.0 to 6.8	0 percentage of participants Interval 0.0 to 6.8	0 percentage of participants Interval 0.0 to 6.8	0 percentage of participants Interval 0.0 to 6.8	0 percentage of participants Interval 0.0 to 6.8	0 percentage of participants Interval 0.0 to 6.8	0 percentage of participants Interval 0.0 to 6.8
Percentage of Participants With Local Reactions by Maximum Severity Within 14 Days After Vaccination Swelling:Any	0 percentage of participants Interval 0.0 to 6.8	5.8 percentage of participants Interval 1.2 to 15.9	1.9 percentage of participants Interval 0.0 to 10.3	3.8 percentage of participants Interval 0.5 to 13.2	5.8 percentage of participants Interval 1.2 to 15.9	0 percentage of participants Interval 0.0 to 6.8	0 percentage of participants Interval 0.0 to 6.8
Percentage of Participants With Local Reactions by Maximum Severity Within 14 Days After Vaccination Swelling:Mild	0 percentage of participants Interval 0.0 to 6.8	1.9 percentage of participants Interval 0.0 to 10.3	1.9 percentage of participants Interval 0.0 to 10.3	3.8 percentage of participants Interval 0.5 to 13.2	5.8 percentage of participants Interval 1.2 to 15.9	0 percentage of participants Interval 0.0 to 6.8	0 percentage of participants Interval 0.0 to 6.8
Percentage of Participants With Local Reactions by Maximum Severity Within 14 Days After Vaccination Swelling:Moderate	0 percentage of participants Interval 0.0 to 6.8	3.8 percentage of participants Interval 0.5 to 13.2	0 percentage of participants Interval 0.0 to 6.8	0 percentage of participants Interval 0.0 to 6.8	0 percentage of participants Interval 0.0 to 6.8	0 percentage of participants Interval 0.0 to 6.8	0 percentage of participants Interval 0.0 to 6.8
Percentage of Participants With Local Reactions by Maximum Severity Within 14 Days After Vaccination Swelling:Grade 4	0 percentage of participants Interval 0.0 to 6.8	0 percentage of participants Interval 0.0 to 6.8	0 percentage of participants Interval 0.0 to 6.8	0 percentage of participants Interval 0.0 to 6.8	0 percentage of participants Interval 0.0 to 6.8	0 percentage of participants Interval 0.0 to 6.8	0 percentage of participants Interval 0.0 to 6.8

PRIMARY outcome

Timeframe: Within 14 days after vaccination

Population: Safety population included all participants who received GBS6 vaccine or placebo.

Fever:38.0-38.4 degree Celsius (C),38.5-38.9 degree C,39.0-40.0 degree C,\>40.0 degree C;nausea/vomiting:mild(not interfered with activity/1-2times in 24 hours\[hr\]),moderate(some interference with activity/\>2times in 24hr),severe(prevented daily activity;required intravenous hydration); diarrhea:mild(2-3 loose stools in 24hr),moderate(4-5 loose stools in 24hr),severe(\>=6 loose stools in 24 hr); headache:mild(not interfered with activity),moderate(repeated use of non-narcotic pain reliever \>24 hr/some interference with activity),severe(significant;any use of narcotic pain reliever/prevented daily activity);fatigue,muscle and joint pain:mild(not interfered with activity), moderate(some interference with activity),severe(significant;prevented daily activity).Prevented daily activity=missed days of work, school/otherwise incapacitating/use of narcotics for analgesia.Nausea/vomiting,diarrhea,headache,fatigue/tiredness,muscle and joint pain: grade 4=emergency room visit or hospitalization.

Outcome measures

Outcome measures
Measure	GBS6 5 Microgram With Aluminum Phosphate n=52 Participants Participants were randomized to receive a single dose of 5 microgram of GBS6 vaccine with aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.	GBS6 5 Microgram Without Aluminum Phosphate n=52 Participants Participants were randomized to receive a single dose of 5 microgram of GBS6 vaccine without aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.	GBS6 10 Microgram With Aluminum Phosphate n=52 Participants Participants were randomized to receive a single dose of 10 microgram of GBS6 vaccine with aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.	GBS6 10 Microgram Without Aluminum Phosphate n=52 Participants Participants were randomized to receive a single dose of 10 microgram of GBS6 vaccine without aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.	GBS6 20 Microgram With Aluminum Phosphate n=52 Participants Participants were randomized to receive a single dose of 20 microgram of GBS6 vaccine with aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months	GBS6 20 Microgram Without Aluminum Phosphate n=52 Participants Participants were randomized to receive a single dose of 20 microgram of GBS6 vaccine without aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.	Placebo n=52 Participants Participants were randomized to receive placebo (saline control) intramuscularly on Day 1 and were followed up to 6 months.
Percentage of Participants With Systemic Events by Maximum Severity Within 14 Days After Vaccination Fever:38.0 to 38.4 degree C	0 percentage of participants Interval 0.0 to 6.8	0 percentage of participants Interval 0.0 to 6.8	0 percentage of participants Interval 0.0 to 6.8	0 percentage of participants Interval 0.0 to 6.8	0 percentage of participants Interval 0.0 to 6.8	1.9 percentage of participants Interval 0.0 to 10.3	0 percentage of participants Interval 0.0 to 6.8
Percentage of Participants With Systemic Events by Maximum Severity Within 14 Days After Vaccination Fever:38.5 to 38.9 degree C	0 percentage of participants Interval 0.0 to 6.8	0 percentage of participants Interval 0.0 to 6.8	0 percentage of participants Interval 0.0 to 6.8	0 percentage of participants Interval 0.0 to 6.8	1.9 percentage of participants Interval 0.0 to 10.3	0 percentage of participants Interval 0.0 to 6.8	1.9 percentage of participants Interval 0.0 to 10.3
Percentage of Participants With Systemic Events by Maximum Severity Within 14 Days After Vaccination Diarrhea:Any	13.5 percentage of participants Interval 5.6 to 25.8	21.2 percentage of participants Interval 11.1 to 34.7	13.5 percentage of participants Interval 5.6 to 25.8	21.2 percentage of participants Interval 11.1 to 34.7	21.2 percentage of participants Interval 11.1 to 34.7	17.3 percentage of participants Interval 8.2 to 30.3	11.5 percentage of participants Interval 4.4 to 23.4
Percentage of Participants With Systemic Events by Maximum Severity Within 14 Days After Vaccination Fatigue/tiredness: Mild	19.2 percentage of participants Interval 9.6 to 32.5	11.5 percentage of participants Interval 4.4 to 23.4	9.6 percentage of participants Interval 3.2 to 21.0	7.7 percentage of participants Interval 2.1 to 18.5	25.0 percentage of participants Interval 14.0 to 38.9	19.2 percentage of participants Interval 9.6 to 32.5	9.6 percentage of participants Interval 3.2 to 21.0
Percentage of Participants With Systemic Events by Maximum Severity Within 14 Days After Vaccination Muscle pain:Moderate	7.7 percentage of participants Interval 2.1 to 18.5	7.7 percentage of participants Interval 2.1 to 18.5	9.6 percentage of participants Interval 3.2 to 21.0	7.7 percentage of participants Interval 2.1 to 18.5	5.8 percentage of participants Interval 1.2 to 15.9	5.8 percentage of participants Interval 1.2 to 15.9	11.5 percentage of participants Interval 4.4 to 23.4
Percentage of Participants With Systemic Events by Maximum Severity Within 14 Days After Vaccination Muscle pain:Severe	0 percentage of participants Interval 0.0 to 6.8	0 percentage of participants Interval 0.0 to 6.8	1.9 percentage of participants Interval 0.0 to 10.3	0 percentage of participants Interval 0.0 to 6.8	0 percentage of participants Interval 0.0 to 6.8	0.0 percentage of participants Interval 0.0 to 6.8	1.9 percentage of participants Interval 0.0 to 10.3
Percentage of Participants With Systemic Events by Maximum Severity Within 14 Days After Vaccination Muscle pain:Grade 4	0 percentage of participants Interval 0.0 to 6.8	0 percentage of participants Interval 0.0 to 6.8	0 percentage of participants Interval 0.0 to 6.8	0 percentage of participants Interval 0.0 to 6.8	0 percentage of participants Interval 0.0 to 6.8	0 percentage of participants Interval 0.0 to 6.8	0 percentage of participants Interval 0.0 to 6.8
Percentage of Participants With Systemic Events by Maximum Severity Within 14 Days After Vaccination Joint pain:Any	13.5 percentage of participants Interval 5.6 to 25.8	9.6 percentage of participants Interval 3.2 to 21.0	13.5 percentage of participants Interval 5.6 to 25.8	9.6 percentage of participants Interval 3.2 to 21.0	13.5 percentage of participants Interval 5.6 to 25.8	11.5 percentage of participants Interval 4.4 to 23.4	5.8 percentage of participants Interval 1.2 to 15.9
Percentage of Participants With Systemic Events by Maximum Severity Within 14 Days After Vaccination Joint pain:Mild	9.6 percentage of participants Interval 3.2 to 21.0	5.8 percentage of participants Interval 1.2 to 15.9	3.8 percentage of participants Interval 0.5 to 13.2	7.7 percentage of participants Interval 2.1 to 18.5	9.6 percentage of participants Interval 3.2 to 21.0	9.6 percentage of participants Interval 3.2 to 21.0	1.9 percentage of participants Interval 0.0 to 10.3
Percentage of Participants With Systemic Events by Maximum Severity Within 14 Days After Vaccination Joint pain:Moderate	3.8 percentage of participants Interval 0.5 to 13.2	3.8 percentage of participants Interval 0.5 to 13.2	9.6 percentage of participants Interval 3.2 to 21.0	1.9 percentage of participants Interval 0.0 to 10.3	3.8 percentage of participants Interval 0.5 to 13.2	1.9 percentage of participants Interval 0.0 to 10.3	3.8 percentage of participants Interval 0.5 to 13.2
Percentage of Participants With Systemic Events by Maximum Severity Within 14 Days After Vaccination Joint pain:Severe	0 percentage of participants Interval 0.0 to 6.8	0 percentage of participants Interval 0.0 to 6.8	0 percentage of participants Interval 0.0 to 6.8	0 percentage of participants Interval 0.0 to 6.8	0 percentage of participants Interval 0.0 to 6.8	0 percentage of participants Interval 0.0 to 6.8	0 percentage of participants Interval 0.0 to 6.8
Percentage of Participants With Systemic Events by Maximum Severity Within 14 Days After Vaccination Joint pain:Grade 4	0 percentage of participants Interval 0.0 to 6.8	0 percentage of participants Interval 0.0 to 6.8	0 percentage of participants Interval 0.0 to 6.8	0 percentage of participants Interval 0.0 to 6.8	0 percentage of participants Interval 0.0 to 6.8	0 percentage of participants Interval 0.0 to 6.8	0 percentage of participants Interval 0.0 to 6.8
Percentage of Participants With Systemic Events by Maximum Severity Within 14 Days After Vaccination Fever:>=38.0 degree C	0 percentage of participants Interval 0.0 to 6.8	0 percentage of participants Interval 0.0 to 6.8	1.9 percentage of participants Interval 0.0 to 10.3	0 percentage of participants Interval 0.0 to 6.8	1.9 percentage of participants Interval 0.0 to 10.3	1.9 percentage of participants Interval 0.0 to 10.3	1.9 percentage of participants Interval 0.0 to 10.3
Percentage of Participants With Systemic Events by Maximum Severity Within 14 Days After Vaccination Fever:39.0 to 40.0 degree C	0 percentage of participants Interval 0.0 to 6.8	0 percentage of participants Interval 0.0 to 6.8	1.9 percentage of participants Interval 0.0 to 10.3	0 percentage of participants Interval 0.0 to 6.8	0 percentage of participants Interval 0.0 to 6.8	0 percentage of participants Interval 0.0 to 6.8	0 percentage of participants Interval 0.0 to 6.8
Percentage of Participants With Systemic Events by Maximum Severity Within 14 Days After Vaccination Fever:>40.0 degree C	0 percentage of participants Interval 0.0 to 6.8	0 percentage of participants Interval 0.0 to 6.8	0 percentage of participants Interval 0.0 to 6.8	0 percentage of participants Interval 0.0 to 6.8	0 percentage of participants Interval 0.0 to 6.8	0 percentage of participants Interval 0.0 to 6.8	0 percentage of participants Interval 0.0 to 6.8
Percentage of Participants With Systemic Events by Maximum Severity Within 14 Days After Vaccination Nausea/vomiting: Any	13.5 percentage of participants Interval 5.6 to 25.8	5.8 percentage of participants Interval 1.2 to 15.9	11.5 percentage of participants Interval 4.4 to 23.4	17.3 percentage of participants Interval 8.2 to 30.3	9.6 percentage of participants Interval 3.2 to 21.0	11.5 percentage of participants Interval 4.4 to 23.4	21.2 percentage of participants Interval 11.1 to 34.7
Percentage of Participants With Systemic Events by Maximum Severity Within 14 Days After Vaccination Nausea/vomiting: Mild	9.6 percentage of participants Interval 3.2 to 21.0	3.8 percentage of participants Interval 0.5 to 13.2	9.6 percentage of participants Interval 3.2 to 21.0	11.5 percentage of participants Interval 4.4 to 23.4	7.7 percentage of participants Interval 2.1 to 18.5	9.6 percentage of participants Interval 3.2 to 21.0	13.5 percentage of participants Interval 5.6 to 25.8
Percentage of Participants With Systemic Events by Maximum Severity Within 14 Days After Vaccination Nausea/vomiting: Moderate	3.8 percentage of participants Interval 0.5 to 13.2	1.9 percentage of participants Interval 0.0 to 10.3	1.9 percentage of participants Interval 0.0 to 10.3	5.8 percentage of participants Interval 1.2 to 15.9	1.9 percentage of participants Interval 0.0 to 10.3	1.9 percentage of participants Interval 0.0 to 10.3	7.7 percentage of participants Interval 2.1 to 18.5
Percentage of Participants With Systemic Events by Maximum Severity Within 14 Days After Vaccination Nausea/vomiting: Severe	0 percentage of participants Interval 0.0 to 6.8	0 percentage of participants Interval 0.0 to 6.8	0 percentage of participants Interval 0.0 to 6.8	0 percentage of participants Interval 0.0 to 6.8	0 percentage of participants Interval 0.0 to 6.8	0 percentage of participants Interval 0.0 to 6.8	0 percentage of participants Interval 0.0 to 6.8
Percentage of Participants With Systemic Events by Maximum Severity Within 14 Days After Vaccination Nausea/vomiting: Grade 4	0 percentage of participants Interval 0.0 to 6.8	0 percentage of participants Interval 0.0 to 6.8	0 percentage of participants Interval 0.0 to 6.8	0 percentage of participants Interval 0.0 to 6.8	0 percentage of participants Interval 0.0 to 6.8	0 percentage of participants Interval 0.0 to 6.8	0 percentage of participants Interval 0.0 to 6.8
Percentage of Participants With Systemic Events by Maximum Severity Within 14 Days After Vaccination Diarrhea:Mild	11.5 percentage of participants Interval 4.4 to 23.4	21.2 percentage of participants Interval 11.1 to 34.7	11.5 percentage of participants Interval 4.4 to 23.4	13.5 percentage of participants Interval 5.6 to 25.8	19.2 percentage of participants Interval 9.6 to 32.5	11.5 percentage of participants Interval 4.4 to 23.4	5.8 percentage of participants Interval 1.2 to 15.9
Percentage of Participants With Systemic Events by Maximum Severity Within 14 Days After Vaccination Diarrhea:Moderate	1.9 percentage of participants Interval 0.0 to 10.3	0 percentage of participants Interval 0.0 to 6.8	1.9 percentage of participants Interval 0.0 to 10.3	3.8 percentage of participants Interval 0.5 to 13.2	0 percentage of participants Interval 0.0 to 6.8	5.8 percentage of participants Interval 1.2 to 15.9	5.8 percentage of participants Interval 1.2 to 15.9
Percentage of Participants With Systemic Events by Maximum Severity Within 14 Days After Vaccination Diarrhea:Severe	0 percentage of participants Interval 0.0 to 6.8	0 percentage of participants Interval 0.0 to 6.8	0 percentage of participants Interval 0.0 to 6.8	3.8 percentage of participants Interval 0.5 to 13.2	1.9 percentage of participants Interval 0.0 to 10.3	0 percentage of participants Interval 0.0 to 6.8	0 percentage of participants Interval 0.0 to 6.8
Percentage of Participants With Systemic Events by Maximum Severity Within 14 Days After Vaccination Diarrhea:Grade 4	0 percentage of participants Interval 0.0 to 6.8	0 percentage of participants Interval 0.0 to 6.8	0 percentage of participants Interval 0.0 to 6.8	0 percentage of participants Interval 0.0 to 6.8	0 percentage of participants Interval 0.0 to 6.8	0 percentage of participants Interval 0.0 to 6.8	0 percentage of participants Interval 0.0 to 6.8
Percentage of Participants With Systemic Events by Maximum Severity Within 14 Days After Vaccination Headache:Any	40.4 percentage of participants Interval 27.0 to 54.9	36.5 percentage of participants Interval 23.6 to 51.0	32.7 percentage of participants Interval 20.3 to 47.1	38.5 percentage of participants Interval 25.3 to 53.0	40.4 percentage of participants Interval 27.0 to 54.9	30.8 percentage of participants Interval 18.7 to 45.1	42.3 percentage of participants Interval 28.7 to 56.8
Percentage of Participants With Systemic Events by Maximum Severity Within 14 Days After Vaccination Headache:Mild	26.9 percentage of participants Interval 15.6 to 41.0	21.2 percentage of participants Interval 11.1 to 34.7	15.4 percentage of participants Interval 6.9 to 28.1	11.5 percentage of participants Interval 4.4 to 23.4	28.8 percentage of participants Interval 17.1 to 43.1	11.5 percentage of participants Interval 4.4 to 23.4	23.1 percentage of participants Interval 12.5 to 36.8
Percentage of Participants With Systemic Events by Maximum Severity Within 14 Days After Vaccination Headache:Moderate	13.5 percentage of participants Interval 5.6 to 25.8	13.5 percentage of participants Interval 5.6 to 25.8	15.4 percentage of participants Interval 6.9 to 28.1	25.0 percentage of participants Interval 14.0 to 38.9	11.5 percentage of participants Interval 4.4 to 23.4	17.3 percentage of participants Interval 8.2 to 30.3	15.4 percentage of participants Interval 6.9 to 28.1
Percentage of Participants With Systemic Events by Maximum Severity Within 14 Days After Vaccination Headache:Severe	0 percentage of participants Interval 0.0 to 6.8	1.9 percentage of participants Interval 0.0 to 10.3	1.9 percentage of participants Interval 0.0 to 10.3	1.9 percentage of participants Interval 0.0 to 10.3	0 percentage of participants Interval 0.0 to 6.8	1.9 percentage of participants Interval 0.0 to 10.3	3.8 percentage of participants Interval 0.5 to 13.2
Percentage of Participants With Systemic Events by Maximum Severity Within 14 Days After Vaccination Headache:Grade 4	0 percentage of participants Interval 0.0 to 6.8	0 percentage of participants Interval 0.0 to 6.8	0 percentage of participants Interval 0.0 to 6.8	0 percentage of participants Interval 0.0 to 6.8	0 percentage of participants Interval 0.0 to 6.8	0 percentage of participants Interval 0.0 to 6.8	0 percentage of participants Interval 0.0 to 6.8
Percentage of Participants With Systemic Events by Maximum Severity Within 14 Days After Vaccination Fatigue/tiredness: Any	42.3 percentage of participants Interval 28.7 to 56.8	32.7 percentage of participants Interval 20.3 to 47.1	34.6 percentage of participants Interval 22.0 to 49.1	26.9 percentage of participants Interval 15.6 to 41.0	50.0 percentage of participants Interval 35.8 to 64.2	38.5 percentage of participants Interval 25.3 to 53.0	34.6 percentage of participants Interval 22.0 to 49.1
Percentage of Participants With Systemic Events by Maximum Severity Within 14 Days After Vaccination Fatigue/tiredness: Moderate	23.1 percentage of participants Interval 12.5 to 36.8	21.2 percentage of participants Interval 11.1 to 34.7	21.2 percentage of participants Interval 11.1 to 34.7	15.4 percentage of participants Interval 6.9 to 28.1	25.0 percentage of participants Interval 14.0 to 38.9	19.2 percentage of participants Interval 9.6 to 32.5	19.2 percentage of participants Interval 9.6 to 32.5
Percentage of Participants With Systemic Events by Maximum Severity Within 14 Days After Vaccination Fatigue/tiredness: Severe	0 percentage of participants Interval 0.0 to 6.8	0 percentage of participants Interval 0.0 to 6.8	3.8 percentage of participants Interval 0.5 to 13.2	3.8 percentage of participants Interval 0.5 to 13.2	0 percentage of participants Interval 0.0 to 6.8	0 percentage of participants Interval 0.0 to 6.8	5.8 percentage of participants Interval 1.2 to 15.9
Percentage of Participants With Systemic Events by Maximum Severity Within 14 Days After Vaccination Fatigue/tiredness:Grade 4	0 percentage of participants Interval 0.0 to 6.8	0 percentage of participants Interval 0.0 to 6.8	0 percentage of participants Interval 0.0 to 6.8	0 percentage of participants Interval 0.0 to 6.8	0 percentage of participants Interval 0.0 to 6.8	0 percentage of participants Interval 0.0 to 6.8	0 percentage of participants Interval 0.0 to 6.8
Percentage of Participants With Systemic Events by Maximum Severity Within 14 Days After Vaccination Muscle pain:Any	17.3 percentage of participants Interval 8.2 to 30.3	25.0 percentage of participants Interval 14.0 to 38.9	19.2 percentage of participants Interval 9.6 to 32.5	19.2 percentage of participants Interval 9.6 to 32.5	19.2 percentage of participants Interval 9.6 to 32.5	23.1 percentage of participants Interval 12.5 to 36.8	19.2 percentage of participants Interval 9.6 to 32.5
Percentage of Participants With Systemic Events by Maximum Severity Within 14 Days After Vaccination Muscle pain:Mild	9.6 percentage of participants Interval 3.2 to 21.0	17.3 percentage of participants Interval 8.2 to 30.3	7.7 percentage of participants Interval 2.1 to 18.5	11.5 percentage of participants Interval 4.4 to 23.4	13.5 percentage of participants Interval 5.6 to 25.8	17.3 percentage of participants Interval 8.2 to 30.3	5.8 percentage of participants Interval 1.2 to 15.9

PRIMARY outcome

Timeframe: Within 1 month after vaccination

Population: Safety population included all participants who received GBS6 vaccine or placebo.

An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly or that was considered to be an important medical event. AEs included both non-serious AEs and SAEs.

Outcome measures

Outcome measures
Measure	GBS6 5 Microgram With Aluminum Phosphate n=52 Participants Participants were randomized to receive a single dose of 5 microgram of GBS6 vaccine with aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.	GBS6 5 Microgram Without Aluminum Phosphate n=52 Participants Participants were randomized to receive a single dose of 5 microgram of GBS6 vaccine without aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.	GBS6 10 Microgram With Aluminum Phosphate n=52 Participants Participants were randomized to receive a single dose of 10 microgram of GBS6 vaccine with aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.	GBS6 10 Microgram Without Aluminum Phosphate n=52 Participants Participants were randomized to receive a single dose of 10 microgram of GBS6 vaccine without aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.	GBS6 20 Microgram With Aluminum Phosphate n=52 Participants Participants were randomized to receive a single dose of 20 microgram of GBS6 vaccine with aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months	GBS6 20 Microgram Without Aluminum Phosphate n=52 Participants Participants were randomized to receive a single dose of 20 microgram of GBS6 vaccine without aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.	Placebo n=52 Participants Participants were randomized to receive placebo (saline control) intramuscularly on Day 1 and were followed up to 6 months.
Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination	19.2 percentage of participants Interval 9.6 to 32.5	5.8 percentage of participants Interval 1.2 to 15.9	19.2 percentage of participants Interval 9.6 to 32.5	13.5 percentage of participants Interval 5.6 to 25.8	26.9 percentage of participants Interval 15.6 to 41.0	28.8 percentage of participants Interval 17.1 to 43.1	21.2 percentage of participants Interval 11.1 to 34.7

PRIMARY outcome

Timeframe: Within 6 months after vaccination

Population: Safety population included all participants who received GBS6 vaccine or placebo.

An AE was any untoward medical occurrence in a participant in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly or that was considered to be an important medical event.

Outcome measures

Outcome measures
Measure	GBS6 5 Microgram With Aluminum Phosphate n=52 Participants Participants were randomized to receive a single dose of 5 microgram of GBS6 vaccine with aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.	GBS6 5 Microgram Without Aluminum Phosphate n=52 Participants Participants were randomized to receive a single dose of 5 microgram of GBS6 vaccine without aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.	GBS6 10 Microgram With Aluminum Phosphate n=52 Participants Participants were randomized to receive a single dose of 10 microgram of GBS6 vaccine with aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.	GBS6 10 Microgram Without Aluminum Phosphate n=52 Participants Participants were randomized to receive a single dose of 10 microgram of GBS6 vaccine without aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.	GBS6 20 Microgram With Aluminum Phosphate n=52 Participants Participants were randomized to receive a single dose of 20 microgram of GBS6 vaccine with aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months	GBS6 20 Microgram Without Aluminum Phosphate n=52 Participants Participants were randomized to receive a single dose of 20 microgram of GBS6 vaccine without aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.	Placebo n=52 Participants Participants were randomized to receive placebo (saline control) intramuscularly on Day 1 and were followed up to 6 months.
Percentage of Participants With Serious Adverse Events (SAEs) Within 6 Month After Vaccination	1.9 percentage of participants Interval 0.0 to 10.3	0 percentage of participants Interval 0.0 to 6.8	1.9 percentage of participants Interval 0.0 to 10.3	0 percentage of participants Interval 0.0 to 6.8	1.9 percentage of participants Interval 0.0 to 10.3	0 percentage of participants Interval 0.0 to 6.8	0 percentage of participants Interval 0.0 to 6.8

PRIMARY outcome

Timeframe: Within 6 months after vaccination

Population: Safety population included all participants who received GBS6 vaccine or placebo.

Outcome measures

Outcome measures
Measure	GBS6 5 Microgram With Aluminum Phosphate n=52 Participants Participants were randomized to receive a single dose of 5 microgram of GBS6 vaccine with aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.	GBS6 5 Microgram Without Aluminum Phosphate n=52 Participants Participants were randomized to receive a single dose of 5 microgram of GBS6 vaccine without aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.	GBS6 10 Microgram With Aluminum Phosphate n=52 Participants Participants were randomized to receive a single dose of 10 microgram of GBS6 vaccine with aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.	GBS6 10 Microgram Without Aluminum Phosphate n=52 Participants Participants were randomized to receive a single dose of 10 microgram of GBS6 vaccine without aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.	GBS6 20 Microgram With Aluminum Phosphate n=52 Participants Participants were randomized to receive a single dose of 20 microgram of GBS6 vaccine with aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months	GBS6 20 Microgram Without Aluminum Phosphate n=52 Participants Participants were randomized to receive a single dose of 20 microgram of GBS6 vaccine without aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.	Placebo n=52 Participants Participants were randomized to receive placebo (saline control) intramuscularly on Day 1 and were followed up to 6 months.
Percentage of Participants With Medically Attended Adverse Events (MAEs) Within 6 Months After Vaccination	21.2 percentage of participants Interval 11.1 to 34.7	23.1 percentage of participants Interval 12.5 to 36.8	28.8 percentage of participants Interval 17.1 to 43.1	19.2 percentage of participants Interval 9.6 to 32.5	34.6 percentage of participants Interval 22.0 to 49.1	26.9 percentage of participants Interval 15.6 to 41.0	34.6 percentage of participants Interval 22.0 to 49.1

SECONDARY outcome

Timeframe: 1 month after vaccination

Population: Evaluable immunogenicity population included all eligible participants who received GBS6 vaccine or placebo, had 1 month after vaccination blood drawn for assay and had at least 1 valid determinate assay result with no major protocol violation. 'Number analyzed' = number of participants with valid, determinate assay results for specified serotype.

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

Outcome measures

Outcome measures
Measure	GBS6 5 Microgram With Aluminum Phosphate n=51 Participants Participants were randomized to receive a single dose of 5 microgram of GBS6 vaccine with aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.	GBS6 5 Microgram Without Aluminum Phosphate n=51 Participants Participants were randomized to receive a single dose of 5 microgram of GBS6 vaccine without aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.	GBS6 10 Microgram With Aluminum Phosphate n=51 Participants Participants were randomized to receive a single dose of 10 microgram of GBS6 vaccine with aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.	GBS6 10 Microgram Without Aluminum Phosphate n=50 Participants Participants were randomized to receive a single dose of 10 microgram of GBS6 vaccine without aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.	GBS6 20 Microgram With Aluminum Phosphate n=52 Participants Participants were randomized to receive a single dose of 20 microgram of GBS6 vaccine with aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months	GBS6 20 Microgram Without Aluminum Phosphate n=52 Participants Participants were randomized to receive a single dose of 20 microgram of GBS6 vaccine without aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.	Placebo n=47 Participants Participants were randomized to receive placebo (saline control) intramuscularly on Day 1 and were followed up to 6 months.
GBS6 Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at 1 Month After Vaccination Ia	30.880 Microgram per milliliter Interval 13.301 to 71.691	20.341 Microgram per milliliter Interval 8.533 to 48.486	24.723 Microgram per milliliter Interval 10.577 to 57.785	41.826 Microgram per milliliter Interval 17.74 to 98.613	21.125 Microgram per milliliter Interval 10.121 to 44.094	17.829 Microgram per milliliter Interval 7.542 to 42.149	0.755 Microgram per milliliter Interval 0.372 to 1.536
GBS6 Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at 1 Month After Vaccination Ib	2.060 Microgram per milliliter Interval 0.891 to 4.762	2.051 Microgram per milliliter Interval 0.952 to 4.417	3.174 Microgram per milliliter Interval 1.368 to 7.365	3.639 Microgram per milliliter Interval 1.426 to 9.289	2.742 Microgram per milliliter Interval 1.102 to 6.82	1.948 Microgram per milliliter Interval 0.785 to 4.836	0.034 Microgram per milliliter Interval 0.019 to 0.059
GBS6 Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at 1 Month After Vaccination III	5.683 Microgram per milliliter Interval 3.002 to 10.76	4.531 Microgram per milliliter Interval 2.29 to 8.965	4.979 Microgram per milliliter Interval 2.346 to 10.571	12.806 Microgram per milliliter Interval 6.221 to 26.365	5.559 Microgram per milliliter Interval 2.724 to 11.345	3.766 Microgram per milliliter Interval 1.887 to 7.517	0.081 Microgram per milliliter Interval 0.054 to 0.122
GBS6 Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at 1 Month After Vaccination IV	2.915 Microgram per milliliter Interval 1.712 to 4.964	5.149 Microgram per milliliter Interval 2.913 to 9.102	4.924 Microgram per milliliter Interval 3.077 to 7.879	4.908 Microgram per milliliter Interval 2.89 to 8.336	4.303 Microgram per milliliter Interval 2.605 to 7.107	7.018 Microgram per milliliter Interval 4.518 to 10.903	0.046 Microgram per milliliter Interval 0.027 to 0.078
GBS6 Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at 1 Month After Vaccination V	2.985 Microgram per milliliter Interval 1.346 to 6.619	3.368 Microgram per milliliter Interval 1.477 to 7.679	4.702 Microgram per milliliter Interval 2.033 to 10.878	5.142 Microgram per milliliter Interval 2.403 to 11.005	3.991 Microgram per milliliter Interval 1.984 to 8.031	6.760 Microgram per milliliter Interval 3.23 to 14.146	0.143 Microgram per milliliter Interval 0.084 to 0.244
GBS6 Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at 1 Month After Vaccination II	31.851 Microgram per milliliter Interval 17.303 to 58.63	21.919 Microgram per milliliter Interval 11.544 to 41.618	26.980 Microgram per milliliter Interval 14.586 to 49.904	57.011 Microgram per milliliter Interval 31.917 to 101.832	37.258 Microgram per milliliter Interval 20.764 to 66.853	31.786 Microgram per milliliter Interval 17.49 to 57.77	0.187 Microgram per milliliter Interval 0.126 to 0.279

Adverse Events

GBS6 5 Microgram With Aluminum Phosphate

Serious events: 1 serious events

Other events: 40 other events

Deaths: 0 deaths

GBS6 5 Microgram Without Aluminum Phosphate

Serious events: 0 serious events

Other events: 35 other events

Deaths: 0 deaths

GBS6 10 Microgram With Aluminum Phosphate

Serious events: 1 serious events

Other events: 39 other events

Deaths: 1 deaths

GBS6 10 Microgram Without Aluminum Phosphate

Serious events: 0 serious events

Other events: 36 other events

Deaths: 0 deaths

GBS6 20 Microgram With Aluminum Phosphate

Serious events: 1 serious events

Other events: 41 other events

Deaths: 0 deaths

GBS6 20 Microgram Without Aluminum Phosphate

Serious events: 0 serious events

Other events: 36 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 35 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	GBS6 5 Microgram With Aluminum Phosphate n=52 participants at risk Participants were randomized to receive a single dose of 5 microgram of GBS6 vaccine with aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.	GBS6 5 Microgram Without Aluminum Phosphate n=52 participants at risk Participants were randomized to receive a single dose of 5 microgram of GBS6 vaccine without aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.	GBS6 10 Microgram With Aluminum Phosphate n=52 participants at risk Participants were randomized to receive a single dose of 10 microgram of GBS6 vaccine with aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.	GBS6 10 Microgram Without Aluminum Phosphate n=52 participants at risk Participants were randomized to receive a single dose of 10 microgram of GBS6 vaccine without aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.	GBS6 20 Microgram With Aluminum Phosphate n=52 participants at risk Participants were randomized to receive a single dose of 20 microgram of GBS6 vaccine with aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months	GBS6 20 Microgram Without Aluminum Phosphate n=52 participants at risk Participants were randomized to receive a single dose of 20 microgram of GBS6 vaccine without aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.	Placebo n=52 participants at risk Participants were randomized to receive placebo (saline control) intramuscularly on Day 1 and were followed up to 6 months.
Metabolism and nutrition disorders Diabetic ketoacidosis	1.9% 1/52 • Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received GBS6 vaccine or placebo.	0.00% 0/52 • Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received GBS6 vaccine or placebo.	0.00% 0/52 • Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received GBS6 vaccine or placebo.	0.00% 0/52 • Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received GBS6 vaccine or placebo.	0.00% 0/52 • Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received GBS6 vaccine or placebo.	0.00% 0/52 • Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received GBS6 vaccine or placebo.	0.00% 0/52 • Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received GBS6 vaccine or placebo.
Psychiatric disorders Completed suicide	0.00% 0/52 • Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received GBS6 vaccine or placebo.	0.00% 0/52 • Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received GBS6 vaccine or placebo.	1.9% 1/52 • Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received GBS6 vaccine or placebo.	0.00% 0/52 • Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received GBS6 vaccine or placebo.	0.00% 0/52 • Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received GBS6 vaccine or placebo.	0.00% 0/52 • Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received GBS6 vaccine or placebo.	0.00% 0/52 • Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received GBS6 vaccine or placebo.
Reproductive system and breast disorders Metrorrhagia	0.00% 0/52 • Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received GBS6 vaccine or placebo.	0.00% 0/52 • Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received GBS6 vaccine or placebo.	0.00% 0/52 • Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received GBS6 vaccine or placebo.	0.00% 0/52 • Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received GBS6 vaccine or placebo.	1.9% 1/52 • Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received GBS6 vaccine or placebo.	0.00% 0/52 • Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received GBS6 vaccine or placebo.	0.00% 0/52 • Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received GBS6 vaccine or placebo.

Other adverse events

Other adverse events
Measure	GBS6 5 Microgram With Aluminum Phosphate n=52 participants at risk Participants were randomized to receive a single dose of 5 microgram of GBS6 vaccine with aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.	GBS6 5 Microgram Without Aluminum Phosphate n=52 participants at risk Participants were randomized to receive a single dose of 5 microgram of GBS6 vaccine without aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.	GBS6 10 Microgram With Aluminum Phosphate n=52 participants at risk Participants were randomized to receive a single dose of 10 microgram of GBS6 vaccine with aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.	GBS6 10 Microgram Without Aluminum Phosphate n=52 participants at risk Participants were randomized to receive a single dose of 10 microgram of GBS6 vaccine without aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.	GBS6 20 Microgram With Aluminum Phosphate n=52 participants at risk Participants were randomized to receive a single dose of 20 microgram of GBS6 vaccine with aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months	GBS6 20 Microgram Without Aluminum Phosphate n=52 participants at risk Participants were randomized to receive a single dose of 20 microgram of GBS6 vaccine without aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.	Placebo n=52 participants at risk Participants were randomized to receive placebo (saline control) intramuscularly on Day 1 and were followed up to 6 months.
Gastrointestinal disorders Diarrhoea	13.5% 7/52 • Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received GBS6 vaccine or placebo.	21.2% 11/52 • Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received GBS6 vaccine or placebo.	13.5% 7/52 • Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received GBS6 vaccine or placebo.	21.2% 11/52 • Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received GBS6 vaccine or placebo.	21.2% 11/52 • Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received GBS6 vaccine or placebo.	17.3% 9/52 • Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received GBS6 vaccine or placebo.	11.5% 6/52 • Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received GBS6 vaccine or placebo.
Gastrointestinal disorders Nausea/vomiting	13.5% 7/52 • Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received GBS6 vaccine or placebo.	5.8% 3/52 • Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received GBS6 vaccine or placebo.	11.5% 6/52 • Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received GBS6 vaccine or placebo.	17.3% 9/52 • Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received GBS6 vaccine or placebo.	9.6% 5/52 • Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received GBS6 vaccine or placebo.	11.5% 6/52 • Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received GBS6 vaccine or placebo.	21.2% 11/52 • Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received GBS6 vaccine or placebo.
General disorders Fatigue	42.3% 22/52 • Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received GBS6 vaccine or placebo.	32.7% 17/52 • Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received GBS6 vaccine or placebo.	34.6% 18/52 • Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received GBS6 vaccine or placebo.	26.9% 14/52 • Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received GBS6 vaccine or placebo.	50.0% 26/52 • Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received GBS6 vaccine or placebo.	38.5% 20/52 • Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received GBS6 vaccine or placebo.	34.6% 18/52 • Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received GBS6 vaccine or placebo.
Infections and infestations Influenza	0.00% 0/52 • Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received GBS6 vaccine or placebo.	0.00% 0/52 • Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received GBS6 vaccine or placebo.	3.8% 2/52 • Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received GBS6 vaccine or placebo.	0.00% 0/52 • Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received GBS6 vaccine or placebo.	0.00% 0/52 • Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received GBS6 vaccine or placebo.	0.00% 0/52 • Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received GBS6 vaccine or placebo.	5.8% 3/52 • Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received GBS6 vaccine or placebo.
Infections and infestations Nasopharyngitis	3.8% 2/52 • Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received GBS6 vaccine or placebo.	0.00% 0/52 • Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received GBS6 vaccine or placebo.	3.8% 2/52 • Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received GBS6 vaccine or placebo.	0.00% 0/52 • Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received GBS6 vaccine or placebo.	1.9% 1/52 • Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received GBS6 vaccine or placebo.	5.8% 3/52 • Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received GBS6 vaccine or placebo.	3.8% 2/52 • Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received GBS6 vaccine or placebo.
Infections and infestations Sinusitis	7.7% 4/52 • Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received GBS6 vaccine or placebo.	3.8% 2/52 • Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received GBS6 vaccine or placebo.	3.8% 2/52 • Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received GBS6 vaccine or placebo.	1.9% 1/52 • Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received GBS6 vaccine or placebo.	3.8% 2/52 • Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received GBS6 vaccine or placebo.	0.00% 0/52 • Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received GBS6 vaccine or placebo.	3.8% 2/52 • Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received GBS6 vaccine or placebo.
Infections and infestations Upper respiratory tract infection	1.9% 1/52 • Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received GBS6 vaccine or placebo.	0.00% 0/52 • Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received GBS6 vaccine or placebo.	5.8% 3/52 • Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received GBS6 vaccine or placebo.	1.9% 1/52 • Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received GBS6 vaccine or placebo.	7.7% 4/52 • Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received GBS6 vaccine or placebo.	11.5% 6/52 • Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received GBS6 vaccine or placebo.	5.8% 3/52 • Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received GBS6 vaccine or placebo.
Injury, poisoning and procedural complications Procedural pain	0.00% 0/52 • Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received GBS6 vaccine or placebo.	0.00% 0/52 • Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received GBS6 vaccine or placebo.	0.00% 0/52 • Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received GBS6 vaccine or placebo.	0.00% 0/52 • Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received GBS6 vaccine or placebo.	1.9% 1/52 • Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received GBS6 vaccine or placebo.	5.8% 3/52 • Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received GBS6 vaccine or placebo.	0.00% 0/52 • Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received GBS6 vaccine or placebo.
Musculoskeletal and connective tissue disorders Arthralgia	13.5% 7/52 • Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received GBS6 vaccine or placebo.	9.6% 5/52 • Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received GBS6 vaccine or placebo.	13.5% 7/52 • Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received GBS6 vaccine or placebo.	9.6% 5/52 • Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received GBS6 vaccine or placebo.	13.5% 7/52 • Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received GBS6 vaccine or placebo.	11.5% 6/52 • Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received GBS6 vaccine or placebo.	5.8% 3/52 • Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received GBS6 vaccine or placebo.
Musculoskeletal and connective tissue disorders Myalgia	17.3% 9/52 • Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received GBS6 vaccine or placebo.	25.0% 13/52 • Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received GBS6 vaccine or placebo.	19.2% 10/52 • Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received GBS6 vaccine or placebo.	19.2% 10/52 • Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received GBS6 vaccine or placebo.	19.2% 10/52 • Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received GBS6 vaccine or placebo.	23.1% 12/52 • Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received GBS6 vaccine or placebo.	19.2% 10/52 • Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received GBS6 vaccine or placebo.
Nervous system disorders Headache	40.4% 21/52 • Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received GBS6 vaccine or placebo.	36.5% 19/52 • Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received GBS6 vaccine or placebo.	32.7% 17/52 • Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received GBS6 vaccine or placebo.	38.5% 20/52 • Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received GBS6 vaccine or placebo.	40.4% 21/52 • Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received GBS6 vaccine or placebo.	30.8% 16/52 • Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received GBS6 vaccine or placebo.	42.3% 22/52 • Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received GBS6 vaccine or placebo.
Nervous system disorders Migraine	0.00% 0/52 • Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received GBS6 vaccine or placebo.	0.00% 0/52 • Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received GBS6 vaccine or placebo.	1.9% 1/52 • Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received GBS6 vaccine or placebo.	1.9% 1/52 • Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received GBS6 vaccine or placebo.	0.00% 0/52 • Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received GBS6 vaccine or placebo.	0.00% 0/52 • Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received GBS6 vaccine or placebo.	5.8% 3/52 • Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received GBS6 vaccine or placebo.
General disorders Injection site pain	53.8% 28/52 • Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received GBS6 vaccine or placebo.	32.7% 17/52 • Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received GBS6 vaccine or placebo.	48.1% 25/52 • Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received GBS6 vaccine or placebo.	38.5% 20/52 • Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received GBS6 vaccine or placebo.	51.9% 27/52 • Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received GBS6 vaccine or placebo.	25.0% 13/52 • Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received GBS6 vaccine or placebo.	15.4% 8/52 • Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received GBS6 vaccine or placebo.
General disorders Injection site swelling	0.00% 0/52 • Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received GBS6 vaccine or placebo.	5.8% 3/52 • Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received GBS6 vaccine or placebo.	1.9% 1/52 • Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received GBS6 vaccine or placebo.	3.8% 2/52 • Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received GBS6 vaccine or placebo.	5.8% 3/52 • Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received GBS6 vaccine or placebo.	0.00% 0/52 • Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received GBS6 vaccine or placebo.	0.00% 0/52 • Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received GBS6 vaccine or placebo.
General disorders Injection site erythema	0.00% 0/52 • Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received GBS6 vaccine or placebo.	3.8% 2/52 • Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received GBS6 vaccine or placebo.	1.9% 1/52 • Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received GBS6 vaccine or placebo.	0.00% 0/52 • Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received GBS6 vaccine or placebo.	5.8% 3/52 • Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received GBS6 vaccine or placebo.	0.00% 0/52 • Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received GBS6 vaccine or placebo.	0.00% 0/52 • Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received GBS6 vaccine or placebo.

Additional Information

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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 publications 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.
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Restriction type: OTHER