Trial Outcomes & Findings for Immunogenicity and Safety of GBS-NN/NN2 in Pregnant Women (NCT NCT05154578)

NCT ID: NCT05154578

Last Updated: 2025-06-11

Results Overview

Concentrations of IgG antibodies specific to the AlpN proteins in μg/mL in cord blood from each baby at birth.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 269 participants
• Primary outcome timeframe: Delivery
• Results posted on: 2025-06-11

Participant Flow

The first participant first visit took place on 17 February 2022 and the last participant last visit took place on 18 October 2023.

A total of 269 maternal participants were enrolled in the study and randomised to one of the 5 study groups.

Participant milestones

Measure	Group 1: 4 Week Dose Interval; 2 Doses Participants received one injection of placebo at 22 (±1) weeks GA (gestational age), one injection of GBS-NN/NN2 at 26 (±1) weeks GA and one injection of GBS- NN/NN2 at 30 (±1) weeks GA GBS-NN/NN2 Vaccine: 0.5 mL GBS-NN/NN2 containing 50 μg of GBS-NN and 50 μg of GBS-NN2 and 0.5 mg of aluminium, given by intramuscular injection. Placebo: 0.5 mL normal saline given by intramuscular injection	Group 2: Early Intervention; 4 Week Dose Interval; 2 Doses Participants received one injection of GBS-NN/NN2 at 22 (±1) weeks GA, one injection of GBS-NN/NN2 at 26 (±1) weeks GA and one injection of placebo at 30 (±1) weeks GA GBS-NN/NN2 Vaccine: 0.5 mL GBS-NN/NN2 containing 50 μg of GBS-NN and 50 μg of GBS-NN2 and 0.5 mg of aluminium, given by intramuscular injection. Placebo: 0.5 mL normal saline given by intramuscular injection	Group 3: Early Intervention; 8 Week Dose Interval; 2 Doses Participants received one injection of GBS-NN/NN2 at 22 (±1) weeks GA, one injection of placebo at 26 (±1) weeks GA and one injection of GBS- NN/NN2 at 30 (±1) weeks GA GBS-NN/NN2 Vaccine: 0.5 mL GBS-NN/NN2 containing 50 μg of GBS-NN and 50 μg of GBS-NN2 and 0.5 mg of aluminium, given by intramuscular injection. Placebo: 0.5 mL normal saline given by intramuscular injection	Group 4: Single Dose Participants received one injection of placebo at 22 (±1) weeks GA, one injection of GBS-NN/NN2 at 26 (±1) weeks GA, and one injection of placebo at 30 (±1) weeks GA. GBS-NN/NN2 Vaccine: 0.5 mL GBS-NN/NN2 containing 50 μg of GBS-NN and 50 μg of GBS-NN2 and 0.5 mg of aluminium, given by intramuscular injection. Placebo: 0.5 mL normal saline given by intramuscular injection	Group 5: Placebo Participants received one injection of placebo at 22, 26 and 30 weeks (±1) GA Placebo: 0.5 mL normal saline given by intramuscular injection
Overall Study STARTED	61	59	59	60	30
Overall Study Number of Live Infant Delivered	61	58	58	57	29
Overall Study COMPLETED	59	54	56	52	29
Overall Study NOT COMPLETED	2	5	3	8	1

Reasons for withdrawal

Measure	Group 1: 4 Week Dose Interval; 2 Doses Participants received one injection of placebo at 22 (±1) weeks GA (gestational age), one injection of GBS-NN/NN2 at 26 (±1) weeks GA and one injection of GBS- NN/NN2 at 30 (±1) weeks GA GBS-NN/NN2 Vaccine: 0.5 mL GBS-NN/NN2 containing 50 μg of GBS-NN and 50 μg of GBS-NN2 and 0.5 mg of aluminium, given by intramuscular injection. Placebo: 0.5 mL normal saline given by intramuscular injection	Group 2: Early Intervention; 4 Week Dose Interval; 2 Doses Participants received one injection of GBS-NN/NN2 at 22 (±1) weeks GA, one injection of GBS-NN/NN2 at 26 (±1) weeks GA and one injection of placebo at 30 (±1) weeks GA GBS-NN/NN2 Vaccine: 0.5 mL GBS-NN/NN2 containing 50 μg of GBS-NN and 50 μg of GBS-NN2 and 0.5 mg of aluminium, given by intramuscular injection. Placebo: 0.5 mL normal saline given by intramuscular injection	Group 3: Early Intervention; 8 Week Dose Interval; 2 Doses Participants received one injection of GBS-NN/NN2 at 22 (±1) weeks GA, one injection of placebo at 26 (±1) weeks GA and one injection of GBS- NN/NN2 at 30 (±1) weeks GA GBS-NN/NN2 Vaccine: 0.5 mL GBS-NN/NN2 containing 50 μg of GBS-NN and 50 μg of GBS-NN2 and 0.5 mg of aluminium, given by intramuscular injection. Placebo: 0.5 mL normal saline given by intramuscular injection	Group 4: Single Dose Participants received one injection of placebo at 22 (±1) weeks GA, one injection of GBS-NN/NN2 at 26 (±1) weeks GA, and one injection of placebo at 30 (±1) weeks GA. GBS-NN/NN2 Vaccine: 0.5 mL GBS-NN/NN2 containing 50 μg of GBS-NN and 50 μg of GBS-NN2 and 0.5 mg of aluminium, given by intramuscular injection. Placebo: 0.5 mL normal saline given by intramuscular injection	Group 5: Placebo Participants received one injection of placebo at 22, 26 and 30 weeks (±1) GA Placebo: 0.5 mL normal saline given by intramuscular injection
Overall Study Withdrawal by Subject	2	3	2	4	0
Overall Study Lost to Follow-up	0	1	0	3	0
Overall Study Adverse Event	0	0	0	1	0
Overall Study Relocated to another province	0	0	1	0	1
Overall Study Baby loss	0	1	0	0	0

Baseline Characteristics

Immunogenicity and Safety of GBS-NN/NN2 in Pregnant Women

Baseline characteristics by cohort

Measure	Group 1: 4 Week Dose Interval; 2 Doses n=61 Participants Participants received one injection of placebo at 22 (±1) weeks GA (gestational age), one injection of GBS-NN/NN2 at 26 (±1) weeks GA and one injection of GBS- NN/NN2 at 30 (±1) weeks GA GBS-NN/NN2 Vaccine: 0.5 mL GBS-NN/NN2 containing 50 μg of GBS-NN and 50 μg of GBS-NN2 and 0.5 mg of aluminium, given by intramuscular injection. Placebo: 0.5 mL normal saline given by intramuscular injection	Group 2: Early Intervention; 4 Week Dose Interval; 2 Doses n=59 Participants Participants received one injection of GBS-NN/NN2 at 22 (±1) weeks GA, one injection of GBS-NN/NN2 at 26 (±1) weeks GA and one injection of placebo at 30 (±1) weeks GA GBS-NN/NN2 Vaccine: 0.5 mL GBS-NN/NN2 containing 50 μg of GBS-NN and 50 μg of GBS-NN2 and 0.5 mg of aluminium, given by intramuscular injection. Placebo: 0.5 mL normal saline given by intramuscular injection	Group 3: Early Intervention; 8 Week Dose Interval; 2 Doses n=59 Participants Participants received one injection of GBS-NN/NN2 at 22 (±1) weeks GA, one injection of placebo at 26 (±1) weeks GA and one injection of GBS- NN/NN2 at 30 (±1) weeks GA GBS-NN/NN2 Vaccine: 0.5 mL GBS-NN/NN2 containing 50 μg of GBS-NN and 50 μg of GBS-NN2 and 0.5 mg of aluminium, given by intramuscular injection. Placebo: 0.5 mL normal saline given by intramuscular injection	Group 4: Single Dose n=60 Participants Participants received one injection of placebo at 22 (±1) weeks GA, one injection of GBS-NN/NN2 at 26 (±1) weeks GA, and one injection of placebo at 30 (±1) weeks GA. GBS-NN/NN2 Vaccine: 0.5 mL GBS-NN/NN2 containing 50 μg of GBS-NN and 50 μg of GBS-NN2 and 0.5 mg of aluminium, given by intramuscular injection. Placebo: 0.5 mL normal saline given by intramuscular injection	Group 5: Placebo n=30 Participants Participants received one injection of placebo at 22, 26 and 30 weeks (±1) GA Placebo: 0.5 mL normal saline given by intramuscular injection	Total n=269 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Age, Categorical Between 18 and 65 years	61 Participants n=5 Participants	59 Participants n=7 Participants	59 Participants n=5 Participants	60 Participants n=4 Participants	30 Participants n=21 Participants	269 Participants n=8 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Age, Continuous	28.9 years STANDARD_DEVIATION 5.26 • n=5 Participants	27.5 years STANDARD_DEVIATION 4.81 • n=7 Participants	27.8 years STANDARD_DEVIATION 5.34 • n=5 Participants	27.3 years STANDARD_DEVIATION 5.37 • n=4 Participants	28.3 years STANDARD_DEVIATION 6.65 • n=21 Participants	27.9 years STANDARD_DEVIATION 5.37 • n=8 Participants
Sex: Female, Male Female	61 Participants n=5 Participants	59 Participants n=7 Participants	59 Participants n=5 Participants	60 Participants n=4 Participants	30 Participants n=21 Participants	269 Participants n=8 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	4 Participants n=8 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	59 Participants n=5 Participants	59 Participants n=7 Participants	58 Participants n=5 Participants	60 Participants n=4 Participants	29 Participants n=21 Participants	265 Participants n=8 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	0 Participants n=21 Participants	3 Participants n=8 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Black or African American	44 Participants n=5 Participants	41 Participants n=7 Participants	43 Participants n=5 Participants	44 Participants n=4 Participants	22 Participants n=21 Participants	194 Participants n=8 Participants
Race (NIH/OMB) White	16 Participants n=5 Participants	18 Participants n=7 Participants	16 Participants n=5 Participants	14 Participants n=4 Participants	8 Participants n=21 Participants	72 Participants n=8 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Region of Enrollment Denmark	13 participants n=5 Participants	14 participants n=7 Participants	12 participants n=5 Participants	13 participants n=4 Participants	7 participants n=21 Participants	59 participants n=8 Participants
Region of Enrollment United Kingdom	4 participants n=5 Participants	3 participants n=7 Participants	4 participants n=5 Participants	3 participants n=4 Participants	1 participants n=21 Participants	15 participants n=8 Participants
Region of Enrollment South Africa	44 participants n=5 Participants	42 participants n=7 Participants	43 participants n=5 Participants	44 participants n=4 Participants	22 participants n=21 Participants	195 participants n=8 Participants
Height	161.7 cm STANDARD_DEVIATION 7.84 • n=5 Participants	162.2 cm STANDARD_DEVIATION 8.00 • n=7 Participants	163.3 cm STANDARD_DEVIATION 7.58 • n=5 Participants	160.5 cm STANDARD_DEVIATION 6.88 • n=4 Participants	160.5 cm STANDARD_DEVIATION 6.92 • n=21 Participants	161.8 cm STANDARD_DEVIATION 7.53 • n=8 Participants
Weight	71.1 kg STANDARD_DEVIATION 14.00 • n=5 Participants	73.0 kg STANDARD_DEVIATION 12.11 • n=7 Participants	73.6 kg STANDARD_DEVIATION 14.52 • n=5 Participants	70.6 kg STANDARD_DEVIATION 14.59 • n=4 Participants	74.2 kg STANDARD_DEVIATION 13.38 • n=21 Participants	72.3 kg STANDARD_DEVIATION 13.76 • n=8 Participants
BMI	27.2 kg/m² STANDARD_DEVIATION 5.28 • n=5 Participants	27.9 kg/m² STANDARD_DEVIATION 5.32 • n=7 Participants	27.6 kg/m² STANDARD_DEVIATION 5.35 • n=5 Participants	27.5 kg/m² STANDARD_DEVIATION 5.57 • n=4 Participants	28.8 kg/m² STANDARD_DEVIATION 5.38 • n=21 Participants	27.7 kg/m² STANDARD_DEVIATION 5.36 • n=8 Participants

PRIMARY outcome

Timeframe: Delivery

Population: Baby Immunogenicicty Set : babies with at least one evaluable sample.

Concentrations of IgG antibodies specific to the AlpN proteins in μg/mL in cord blood from each baby at birth.

Outcome measures

Measure	Group 1: 4 Week Dose Interval; 2 Doses (Infant Participants) n=43 Participants Infants of participants from group 1, who received one injection of placebo at 22 (±1) weeks GA, one injection of GBS-NN/NN2 at 26 (±1) weeks GA and one injection of GBS- NN/NN2 at 30 (±1) weeks GA	Group 2: Early Intervention; 4 Week Dose Interval; 2 Doses (Infant Participants) n=47 Participants Infants of participants from group 2, who received one injection of GBS-NN/NN2 at 22 (±1) weeks GA, one injection of GBS-NN/NN2 at 26 (±1) weeks GA and one injection of placebo at 30 (±1) weeks GA	Group 3: Early Intervention; 8 Week Dose Interval; 2 Doses (Infant Participants) n=47 Participants Infants of participant of group 3, who received one injection of GBS-NN/NN2 at 22 (±1) weeks GA, one injection of placebo at 26 (±1) weeks GA and one injection of GBS- NN/NN2 at 30 (±1) weeks GA	Group 4: Single Dose (Infant Participants) n=37 Participants Infants of participants from group 4, who received one injection of placebo at 22 (±1) weeks GA, one injection of GBS-NN/NN2 at 26 (±1) weeks GA, and one injection of placebo at 30 (±1) weeks GA	Group 5: Placebo (Infant Participants) n=20 Participants Infant of participants from group 5, who received one injection of placebo at 22, 26 and 30 weeks (±1) GA
Concentrations of Immunoglobulin (Ig) G Antibodies Specific to the AlpN Proteins in μg/mL in Cord Blood From Each Baby Alp1N	11.12 μg/mL Geometric Coefficient of Variation 236.7	5.52 μg/mL Geometric Coefficient of Variation 183.9	7.95 μg/mL Geometric Coefficient of Variation 261.6	3.51 μg/mL Geometric Coefficient of Variation 565.2	0.07 μg/mL Geometric Coefficient of Variation 102.2
Concentrations of Immunoglobulin (Ig) G Antibodies Specific to the AlpN Proteins in μg/mL in Cord Blood From Each Baby Alp2N	7.93 μg/mL Geometric Coefficient of Variation 164.0	5.32 μg/mL Geometric Coefficient of Variation 280.9	5.46 μg/mL Geometric Coefficient of Variation 445.7	3.39 μg/mL Geometric Coefficient of Variation 717.6	0.04 μg/mL Geometric Coefficient of Variation 112.9
Concentrations of Immunoglobulin (Ig) G Antibodies Specific to the AlpN Proteins in μg/mL in Cord Blood From Each Baby AlpCN	8.85 μg/mL Geometric Coefficient of Variation 246.7	6.71 μg/mL Geometric Coefficient of Variation 337.4	7.39 μg/mL Geometric Coefficient of Variation 374.6	3.10 μg/mL Geometric Coefficient of Variation 682.0	0.06 μg/mL Geometric Coefficient of Variation 137.5
Concentrations of Immunoglobulin (Ig) G Antibodies Specific to the AlpN Proteins in μg/mL in Cord Blood From Each Baby RibN	3.67 μg/mL Geometric Coefficient of Variation 157.6	1.76 μg/mL Geometric Coefficient of Variation 434.2	3.23 μg/mL Geometric Coefficient of Variation 283.3	1.28 μg/mL Geometric Coefficient of Variation 520.6	0.06 μg/mL Geometric Coefficient of Variation 129.4

SECONDARY outcome

Timeframe: 7 days following each injection

Number of participants with solicited injection site reactions following vaccination

Outcome measures

Measure	Group 1: 4 Week Dose Interval; 2 Doses (Infant Participants) n=61 Participants Infants of participants from group 1, who received one injection of placebo at 22 (±1) weeks GA, one injection of GBS-NN/NN2 at 26 (±1) weeks GA and one injection of GBS- NN/NN2 at 30 (±1) weeks GA	Group 2: Early Intervention; 4 Week Dose Interval; 2 Doses (Infant Participants) n=59 Participants Infants of participants from group 2, who received one injection of GBS-NN/NN2 at 22 (±1) weeks GA, one injection of GBS-NN/NN2 at 26 (±1) weeks GA and one injection of placebo at 30 (±1) weeks GA	Group 3: Early Intervention; 8 Week Dose Interval; 2 Doses (Infant Participants) n=59 Participants Infants of participant of group 3, who received one injection of GBS-NN/NN2 at 22 (±1) weeks GA, one injection of placebo at 26 (±1) weeks GA and one injection of GBS- NN/NN2 at 30 (±1) weeks GA	Group 4: Single Dose (Infant Participants) n=60 Participants Infants of participants from group 4, who received one injection of placebo at 22 (±1) weeks GA, one injection of GBS-NN/NN2 at 26 (±1) weeks GA, and one injection of placebo at 30 (±1) weeks GA	Group 5: Placebo (Infant Participants) n=30 Participants Infant of participants from group 5, who received one injection of placebo at 22, 26 and 30 weeks (±1) GA
Injection Site Reactions in the Mother Redness : 0 - 2.4 cm	7 participants	5 participants	9 participants	5 participants	5 participants
Injection Site Reactions in the Mother Redness : 2.5 - 5.0 cm	2 participants	1 participants	2 participants	0 participants	0 participants
Injection Site Reactions in the Mother Redness : 5.1 - 10.0 cm	0 participants	1 participants	0 participants	0 participants	0 participants
Injection Site Reactions in the Mother Redness : >10 cm	0 participants	0 participants	0 participants	0 participants	0 participants
Injection Site Reactions in the Mother Swelling : Palpable "firmness" only	14 participants	10 participants	9 participants	6 participants	1 participants
Injection Site Reactions in the Mother Swelling : 0 - 2.4 cm	5 participants	2 participants	2 participants	2 participants	0 participants
Injection Site Reactions in the Mother Swelling : 2.5 - 5.0 cm	0 participants	2 participants	0 participants	0 participants	0 participants
Injection Site Reactions in the Mother Swelling : 5.1 - 10.0 cm	0 participants	0 participants	0 participants	0 participants	0 participants
Injection Site Reactions in the Mother Tenderness: Mild	14 participants	17 participants	18 participants	16 participants	3 participants
Injection Site Reactions in the Mother Tenderness: Moderate	15 participants	12 participants	13 participants	10 participants	1 participants
Injection Site Reactions in the Mother Tenderness: Severe	0 participants	0 participants	1 participants	0 participants	0 participants
Injection Site Reactions in the Mother Itching	23 participants	20 participants	15 participants	14 participants	4 participants
Injection Site Reactions in the Mother Pain: Mild	35 participants	35 participants	34 participants	24 participants	3 participants
Injection Site Reactions in the Mother Pain: Moderate	3 participants	3 participants	2 participants	0 participants	0 participants
Injection Site Reactions in the Mother Pain: Severe	0 participants	0 participants	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: To Day 84

Number of participants with solicited and other adverse events following the vaccinations

Outcome measures

Measure	Group 1: 4 Week Dose Interval; 2 Doses (Infant Participants) n=61 Participants Infants of participants from group 1, who received one injection of placebo at 22 (±1) weeks GA, one injection of GBS-NN/NN2 at 26 (±1) weeks GA and one injection of GBS- NN/NN2 at 30 (±1) weeks GA	Group 2: Early Intervention; 4 Week Dose Interval; 2 Doses (Infant Participants) n=59 Participants Infants of participants from group 2, who received one injection of GBS-NN/NN2 at 22 (±1) weeks GA, one injection of GBS-NN/NN2 at 26 (±1) weeks GA and one injection of placebo at 30 (±1) weeks GA	Group 3: Early Intervention; 8 Week Dose Interval; 2 Doses (Infant Participants) n=59 Participants Infants of participant of group 3, who received one injection of GBS-NN/NN2 at 22 (±1) weeks GA, one injection of placebo at 26 (±1) weeks GA and one injection of GBS- NN/NN2 at 30 (±1) weeks GA	Group 4: Single Dose (Infant Participants) n=60 Participants Infants of participants from group 4, who received one injection of placebo at 22 (±1) weeks GA, one injection of GBS-NN/NN2 at 26 (±1) weeks GA, and one injection of placebo at 30 (±1) weeks GA	Group 5: Placebo (Infant Participants) n=30 Participants Infant of participants from group 5, who received one injection of placebo at 22, 26 and 30 weeks (±1) GA
Adverse Events Following the Vaccinations in the Mother	56 participants	54 participants	57 participants	56 participants	26 participants

SECONDARY outcome

Timeframe: To Day 84

Number of participants with clinically significant abnormal laboratory tests in the mother

Outcome measures

Measure	Group 1: 4 Week Dose Interval; 2 Doses (Infant Participants) n=61 Participants Infants of participants from group 1, who received one injection of placebo at 22 (±1) weeks GA, one injection of GBS-NN/NN2 at 26 (±1) weeks GA and one injection of GBS- NN/NN2 at 30 (±1) weeks GA	Group 2: Early Intervention; 4 Week Dose Interval; 2 Doses (Infant Participants) n=59 Participants Infants of participants from group 2, who received one injection of GBS-NN/NN2 at 22 (±1) weeks GA, one injection of GBS-NN/NN2 at 26 (±1) weeks GA and one injection of placebo at 30 (±1) weeks GA	Group 3: Early Intervention; 8 Week Dose Interval; 2 Doses (Infant Participants) n=59 Participants Infants of participant of group 3, who received one injection of GBS-NN/NN2 at 22 (±1) weeks GA, one injection of placebo at 26 (±1) weeks GA and one injection of GBS- NN/NN2 at 30 (±1) weeks GA	Group 4: Single Dose (Infant Participants) n=60 Participants Infants of participants from group 4, who received one injection of placebo at 22 (±1) weeks GA, one injection of GBS-NN/NN2 at 26 (±1) weeks GA, and one injection of placebo at 30 (±1) weeks GA	Group 5: Placebo (Infant Participants) n=30 Participants Infant of participants from group 5, who received one injection of placebo at 22, 26 and 30 weeks (±1) GA
Clinically Significant Abnormal Laboratory Tests in the Mother	0 participants	0 participants	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: To Day 84

Number of participants with clinically significant changes in vital signs (heart rate, blood pressure, oral temperature) in the mother

Outcome measures

Measure	Group 1: 4 Week Dose Interval; 2 Doses (Infant Participants) n=61 Participants Infants of participants from group 1, who received one injection of placebo at 22 (±1) weeks GA, one injection of GBS-NN/NN2 at 26 (±1) weeks GA and one injection of GBS- NN/NN2 at 30 (±1) weeks GA	Group 2: Early Intervention; 4 Week Dose Interval; 2 Doses (Infant Participants) n=59 Participants Infants of participants from group 2, who received one injection of GBS-NN/NN2 at 22 (±1) weeks GA, one injection of GBS-NN/NN2 at 26 (±1) weeks GA and one injection of placebo at 30 (±1) weeks GA	Group 3: Early Intervention; 8 Week Dose Interval; 2 Doses (Infant Participants) n=59 Participants Infants of participant of group 3, who received one injection of GBS-NN/NN2 at 22 (±1) weeks GA, one injection of placebo at 26 (±1) weeks GA and one injection of GBS- NN/NN2 at 30 (±1) weeks GA	Group 4: Single Dose (Infant Participants) n=60 Participants Infants of participants from group 4, who received one injection of placebo at 22 (±1) weeks GA, one injection of GBS-NN/NN2 at 26 (±1) weeks GA, and one injection of placebo at 30 (±1) weeks GA	Group 5: Placebo (Infant Participants) n=30 Participants Infant of participants from group 5, who received one injection of placebo at 22, 26 and 30 weeks (±1) GA
Clinically Significant Changes in Vital Signs in the Mother	0 participants	0 participants	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: To Day 84

Number of participants with clinically significant changes in physical examination in the mother

Outcome measures

Measure	Group 1: 4 Week Dose Interval; 2 Doses (Infant Participants) n=61 Participants Infants of participants from group 1, who received one injection of placebo at 22 (±1) weeks GA, one injection of GBS-NN/NN2 at 26 (±1) weeks GA and one injection of GBS- NN/NN2 at 30 (±1) weeks GA	Group 2: Early Intervention; 4 Week Dose Interval; 2 Doses (Infant Participants) n=59 Participants Infants of participants from group 2, who received one injection of GBS-NN/NN2 at 22 (±1) weeks GA, one injection of GBS-NN/NN2 at 26 (±1) weeks GA and one injection of placebo at 30 (±1) weeks GA	Group 3: Early Intervention; 8 Week Dose Interval; 2 Doses (Infant Participants) n=59 Participants Infants of participant of group 3, who received one injection of GBS-NN/NN2 at 22 (±1) weeks GA, one injection of placebo at 26 (±1) weeks GA and one injection of GBS- NN/NN2 at 30 (±1) weeks GA	Group 4: Single Dose (Infant Participants) n=60 Participants Infants of participants from group 4, who received one injection of placebo at 22 (±1) weeks GA, one injection of GBS-NN/NN2 at 26 (±1) weeks GA, and one injection of placebo at 30 (±1) weeks GA	Group 5: Placebo (Infant Participants) n=30 Participants Infant of participants from group 5, who received one injection of placebo at 22, 26 and 30 weeks (±1) GA
Clinically Significant Changes in Physical Examination in the Mother	0 participants	0 participants	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: Delivery

Population: Baby safety analysis set

Gestational age at birth

Outcome measures

Measure	Group 1: 4 Week Dose Interval; 2 Doses (Infant Participants) n=61 Participants Infants of participants from group 1, who received one injection of placebo at 22 (±1) weeks GA, one injection of GBS-NN/NN2 at 26 (±1) weeks GA and one injection of GBS- NN/NN2 at 30 (±1) weeks GA	Group 2: Early Intervention; 4 Week Dose Interval; 2 Doses (Infant Participants) n=58 Participants Infants of participants from group 2, who received one injection of GBS-NN/NN2 at 22 (±1) weeks GA, one injection of GBS-NN/NN2 at 26 (±1) weeks GA and one injection of placebo at 30 (±1) weeks GA	Group 3: Early Intervention; 8 Week Dose Interval; 2 Doses (Infant Participants) n=58 Participants Infants of participant of group 3, who received one injection of GBS-NN/NN2 at 22 (±1) weeks GA, one injection of placebo at 26 (±1) weeks GA and one injection of GBS- NN/NN2 at 30 (±1) weeks GA	Group 4: Single Dose (Infant Participants) n=57 Participants Infants of participants from group 4, who received one injection of placebo at 22 (±1) weeks GA, one injection of GBS-NN/NN2 at 26 (±1) weeks GA, and one injection of placebo at 30 (±1) weeks GA	Group 5: Placebo (Infant Participants) n=29 Participants Infant of participants from group 5, who received one injection of placebo at 22, 26 and 30 weeks (±1) GA
Gestational Age	38.7 weeks Standard Deviation 2.88	38.9 weeks Standard Deviation 2.39	38.9 weeks Standard Deviation 2.30	38.8 weeks Standard Deviation 2.37	39.4 weeks Standard Deviation 1.45

SECONDARY outcome

Timeframe: Delivery

Population: Baby safety analysis set

Weight of the baby

Outcome measures

Measure	Group 1: 4 Week Dose Interval; 2 Doses (Infant Participants) n=61 Participants Infants of participants from group 1, who received one injection of placebo at 22 (±1) weeks GA, one injection of GBS-NN/NN2 at 26 (±1) weeks GA and one injection of GBS- NN/NN2 at 30 (±1) weeks GA	Group 2: Early Intervention; 4 Week Dose Interval; 2 Doses (Infant Participants) n=58 Participants Infants of participants from group 2, who received one injection of GBS-NN/NN2 at 22 (±1) weeks GA, one injection of GBS-NN/NN2 at 26 (±1) weeks GA and one injection of placebo at 30 (±1) weeks GA	Group 3: Early Intervention; 8 Week Dose Interval; 2 Doses (Infant Participants) n=58 Participants Infants of participant of group 3, who received one injection of GBS-NN/NN2 at 22 (±1) weeks GA, one injection of placebo at 26 (±1) weeks GA and one injection of GBS- NN/NN2 at 30 (±1) weeks GA	Group 4: Single Dose (Infant Participants) n=57 Participants Infants of participants from group 4, who received one injection of placebo at 22 (±1) weeks GA, one injection of GBS-NN/NN2 at 26 (±1) weeks GA, and one injection of placebo at 30 (±1) weeks GA	Group 5: Placebo (Infant Participants) n=29 Participants Infant of participants from group 5, who received one injection of placebo at 22, 26 and 30 weeks (±1) GA
Weight of the Baby	3165.4 grams Standard Deviation 585.45	3086.5 grams Standard Deviation 679.50	3230.1 grams Standard Deviation 638.71	2955.3 grams Standard Deviation 598.35	3272.4 grams Standard Deviation 629.20

SECONDARY outcome

Timeframe: Delivery

Population: Baby safety analysis set

Length of the baby

Outcome measures

Measure	Group 1: 4 Week Dose Interval; 2 Doses (Infant Participants) n=61 Participants Infants of participants from group 1, who received one injection of placebo at 22 (±1) weeks GA, one injection of GBS-NN/NN2 at 26 (±1) weeks GA and one injection of GBS- NN/NN2 at 30 (±1) weeks GA	Group 2: Early Intervention; 4 Week Dose Interval; 2 Doses (Infant Participants) n=58 Participants Infants of participants from group 2, who received one injection of GBS-NN/NN2 at 22 (±1) weeks GA, one injection of GBS-NN/NN2 at 26 (±1) weeks GA and one injection of placebo at 30 (±1) weeks GA	Group 3: Early Intervention; 8 Week Dose Interval; 2 Doses (Infant Participants) n=58 Participants Infants of participant of group 3, who received one injection of GBS-NN/NN2 at 22 (±1) weeks GA, one injection of placebo at 26 (±1) weeks GA and one injection of GBS- NN/NN2 at 30 (±1) weeks GA	Group 4: Single Dose (Infant Participants) n=57 Participants Infants of participants from group 4, who received one injection of placebo at 22 (±1) weeks GA, one injection of GBS-NN/NN2 at 26 (±1) weeks GA, and one injection of placebo at 30 (±1) weeks GA	Group 5: Placebo (Infant Participants) n=29 Participants Infant of participants from group 5, who received one injection of placebo at 22, 26 and 30 weeks (±1) GA
Length of the Baby	50.3 centimeters Standard Deviation 3.59	49.9 centimeters Standard Deviation 2.96	49.3 centimeters Standard Deviation 4.88	48.9 centimeters Standard Deviation 4.42	49.7 centimeters Standard Deviation 4.45

SECONDARY outcome

Timeframe: Delivery

Population: Baby safety analysis set

Head circumference of the baby

Outcome measures

Measure	Group 1: 4 Week Dose Interval; 2 Doses (Infant Participants) n=61 Participants Infants of participants from group 1, who received one injection of placebo at 22 (±1) weeks GA, one injection of GBS-NN/NN2 at 26 (±1) weeks GA and one injection of GBS- NN/NN2 at 30 (±1) weeks GA	Group 2: Early Intervention; 4 Week Dose Interval; 2 Doses (Infant Participants) n=58 Participants Infants of participants from group 2, who received one injection of GBS-NN/NN2 at 22 (±1) weeks GA, one injection of GBS-NN/NN2 at 26 (±1) weeks GA and one injection of placebo at 30 (±1) weeks GA	Group 3: Early Intervention; 8 Week Dose Interval; 2 Doses (Infant Participants) n=58 Participants Infants of participant of group 3, who received one injection of GBS-NN/NN2 at 22 (±1) weeks GA, one injection of placebo at 26 (±1) weeks GA and one injection of GBS- NN/NN2 at 30 (±1) weeks GA	Group 4: Single Dose (Infant Participants) n=57 Participants Infants of participants from group 4, who received one injection of placebo at 22 (±1) weeks GA, one injection of GBS-NN/NN2 at 26 (±1) weeks GA, and one injection of placebo at 30 (±1) weeks GA	Group 5: Placebo (Infant Participants) n=29 Participants Infant of participants from group 5, who received one injection of placebo at 22, 26 and 30 weeks (±1) GA
Head Circumference of the Baby	34.4 centimeters Standard Deviation 1.83	34.3 centimeters Standard Deviation 1.68	33.8 centimeters Standard Deviation 2.49	34.0 centimeters Standard Deviation 2.19	34.8 centimeters Standard Deviation 1.60

SECONDARY outcome

Timeframe: 1, 5 and 10 minutes

Population: Baby safety analysis set

Apgar score in the baby (Appearance; Pulse; Grimace response; Activity; Respiration).

Range 0 to 10 where high scores are good and low scores are bad.

Outcome measures

Measure	Group 1: 4 Week Dose Interval; 2 Doses (Infant Participants) n=61 Participants Infants of participants from group 1, who received one injection of placebo at 22 (±1) weeks GA, one injection of GBS-NN/NN2 at 26 (±1) weeks GA and one injection of GBS- NN/NN2 at 30 (±1) weeks GA	Group 2: Early Intervention; 4 Week Dose Interval; 2 Doses (Infant Participants) n=58 Participants Infants of participants from group 2, who received one injection of GBS-NN/NN2 at 22 (±1) weeks GA, one injection of GBS-NN/NN2 at 26 (±1) weeks GA and one injection of placebo at 30 (±1) weeks GA	Group 3: Early Intervention; 8 Week Dose Interval; 2 Doses (Infant Participants) n=58 Participants Infants of participant of group 3, who received one injection of GBS-NN/NN2 at 22 (±1) weeks GA, one injection of placebo at 26 (±1) weeks GA and one injection of GBS- NN/NN2 at 30 (±1) weeks GA	Group 4: Single Dose (Infant Participants) n=57 Participants Infants of participants from group 4, who received one injection of placebo at 22 (±1) weeks GA, one injection of GBS-NN/NN2 at 26 (±1) weeks GA, and one injection of placebo at 30 (±1) weeks GA	Group 5: Placebo (Infant Participants) n=29 Participants Infant of participants from group 5, who received one injection of placebo at 22, 26 and 30 weeks (±1) GA
Apgar Score in the Baby APGAR score at 1 minute	8.8 score on a scale Standard Deviation 1.39	9.0 score on a scale Standard Deviation 0.91	8.8 score on a scale Standard Deviation 1.00	8.9 score on a scale Standard Deviation 1.38	8.8 score on a scale Standard Deviation 1.22
Apgar Score in the Baby APGAR score at 5 minutes	9.7 score on a scale Standard Deviation 1.34	9.8 score on a scale Standard Deviation 0.54	9.8 score on a scale Standard Deviation 0.60	9.9 score on a scale Standard Deviation 0.32	9.8 score on a scale Standard Deviation 0.62
Apgar Score in the Baby APGAR score at 10 minutes	9.9 score on a scale Standard Deviation 0.29	9.9 score on a scale Standard Deviation 0.28	9.9 score on a scale Standard Deviation 0.33	9.9 score on a scale Standard Deviation 0.29	10.0 score on a scale Standard Deviation 0.00

SECONDARY outcome

Timeframe: Delivery

Population: Baby Immunogenicicty Set : babies with at least one evaluable sample.

Concentrations of IgG antibodies specific to the AlpN proteins in μg/mL in maternal blood

Outcome measures

Measure	Group 1: 4 Week Dose Interval; 2 Doses (Infant Participants) n=61 Participants Infants of participants from group 1, who received one injection of placebo at 22 (±1) weeks GA, one injection of GBS-NN/NN2 at 26 (±1) weeks GA and one injection of GBS- NN/NN2 at 30 (±1) weeks GA	Group 2: Early Intervention; 4 Week Dose Interval; 2 Doses (Infant Participants) n=59 Participants Infants of participants from group 2, who received one injection of GBS-NN/NN2 at 22 (±1) weeks GA, one injection of GBS-NN/NN2 at 26 (±1) weeks GA and one injection of placebo at 30 (±1) weeks GA	Group 3: Early Intervention; 8 Week Dose Interval; 2 Doses (Infant Participants) n=59 Participants Infants of participant of group 3, who received one injection of GBS-NN/NN2 at 22 (±1) weeks GA, one injection of placebo at 26 (±1) weeks GA and one injection of GBS- NN/NN2 at 30 (±1) weeks GA	Group 4: Single Dose (Infant Participants) n=60 Participants Infants of participants from group 4, who received one injection of placebo at 22 (±1) weeks GA, one injection of GBS-NN/NN2 at 26 (±1) weeks GA, and one injection of placebo at 30 (±1) weeks GA	Group 5: Placebo (Infant Participants) n=30 Participants Infant of participants from group 5, who received one injection of placebo at 22, 26 and 30 weeks (±1) GA
Concentrations of IgG Antibodies Specific to the AlpN Proteins in μg/mL in Maternal Blood Alp1N	40.57 μg/mL Geometric Coefficient of Variation 271.0	15.81 μg/mL Geometric Coefficient of Variation 295.1	32.91 μg/mL Geometric Coefficient of Variation 322.2	12.38 μg/mL Geometric Coefficient of Variation 604.4	1.03 μg/mL Geometric Coefficient of Variation 85.3
Concentrations of IgG Antibodies Specific to the AlpN Proteins in μg/mL in Maternal Blood Alp2N	61.69 μg/mL Geometric Coefficient of Variation 384.9	32.74 μg/mL Geometric Coefficient of Variation 275.1	39.54 μg/mL Geometric Coefficient of Variation 239.9	18.96 μg/mL Geometric Coefficient of Variation 491.4	1.02 μg/mL Geometric Coefficient of Variation 95.9
Concentrations of IgG Antibodies Specific to the AlpN Proteins in μg/mL in Maternal Blood AlpCN	48.11 μg/mL Geometric Coefficient of Variation 314.7	25.17 μg/mL Geometric Coefficient of Variation 328.6	27.53 μg/mL Geometric Coefficient of Variation 332.7	16.38 μg/mL Geometric Coefficient of Variation 482.6	1.10 μg/mL Geometric Coefficient of Variation 86.4
Concentrations of IgG Antibodies Specific to the AlpN Proteins in μg/mL in Maternal Blood RibN	25.55 μg/mL Geometric Coefficient of Variation 323.2	10.97 μg/mL Geometric Coefficient of Variation 305.5	20.08 μg/mL Geometric Coefficient of Variation 473.4	8.68 μg/mL Geometric Coefficient of Variation 614.4	0.92 μg/mL Geometric Coefficient of Variation 74.4

SECONDARY outcome

Timeframe: 1 month, 3 months

Population: Baby Immunogenicicty Set : babies with at least one evaluable sample.

Concentrations of IgG antibodies specific to the AlpN proteins in μg/mL in blood from each baby

Outcome measures

Measure	Group 1: 4 Week Dose Interval; 2 Doses (Infant Participants) n=43 Participants Infants of participants from group 1, who received one injection of placebo at 22 (±1) weeks GA, one injection of GBS-NN/NN2 at 26 (±1) weeks GA and one injection of GBS- NN/NN2 at 30 (±1) weeks GA	Group 2: Early Intervention; 4 Week Dose Interval; 2 Doses (Infant Participants) n=47 Participants Infants of participants from group 2, who received one injection of GBS-NN/NN2 at 22 (±1) weeks GA, one injection of GBS-NN/NN2 at 26 (±1) weeks GA and one injection of placebo at 30 (±1) weeks GA	Group 3: Early Intervention; 8 Week Dose Interval; 2 Doses (Infant Participants) n=47 Participants Infants of participant of group 3, who received one injection of GBS-NN/NN2 at 22 (±1) weeks GA, one injection of placebo at 26 (±1) weeks GA and one injection of GBS- NN/NN2 at 30 (±1) weeks GA	Group 4: Single Dose (Infant Participants) n=37 Participants Infants of participants from group 4, who received one injection of placebo at 22 (±1) weeks GA, one injection of GBS-NN/NN2 at 26 (±1) weeks GA, and one injection of placebo at 30 (±1) weeks GA	Group 5: Placebo (Infant Participants) n=20 Participants Infant of participants from group 5, who received one injection of placebo at 22, 26 and 30 weeks (±1) GA
Concentrations of IgG Antibodies Specific to the AlpN Proteins in μg/mL in Blood From Each Baby Alp2N: At 3 months of age	1.73 μg/mL Geometric Coefficient of Variation 239.6	1.05 μg/mL Geometric Coefficient of Variation 256.2	1.37 μg/mL Geometric Coefficient of Variation 247.2	0.59 μg/mL Geometric Coefficient of Variation 427.3	0.02 μg/mL Geometric Coefficient of Variation 102.0
Concentrations of IgG Antibodies Specific to the AlpN Proteins in μg/mL in Blood From Each Baby AlpCN: At 1 month of age	4.90 μg/mL Geometric Coefficient of Variation 495.8	3.44 μg/mL Geometric Coefficient of Variation 264.8	4.64 μg/mL Geometric Coefficient of Variation 399.0	1.50 μg/mL Geometric Coefficient of Variation 1065.8	0.07 μg/mL Geometric Coefficient of Variation 384.9
Concentrations of IgG Antibodies Specific to the AlpN Proteins in μg/mL in Blood From Each Baby AlpCN: At 3 months of age	1.92 μg/mL Geometric Coefficient of Variation 289.2	1.15 μg/mL Geometric Coefficient of Variation 323.8	1.67 μg/mL Geometric Coefficient of Variation 214.1	0.49 μg/mL Geometric Coefficient of Variation 436.0	0.03 μg/mL Geometric Coefficient of Variation 106.5
Concentrations of IgG Antibodies Specific to the AlpN Proteins in μg/mL in Blood From Each Baby RibN: At 1 month of age	2.46 μg/mL Geometric Coefficient of Variation 190.5	1.13 μg/mL Geometric Coefficient of Variation 223.6	2.13 μg/mL Geometric Coefficient of Variation 264.1	0.77 μg/mL Geometric Coefficient of Variation 560.9	0.05 μg/mL Geometric Coefficient of Variation 237.2
Concentrations of IgG Antibodies Specific to the AlpN Proteins in μg/mL in Blood From Each Baby RibN: At 3 months of age	0.88 μg/mL Geometric Coefficient of Variation 190.2	0.45 μg/mL Geometric Coefficient of Variation 219.1	0.78 μg/mL Geometric Coefficient of Variation 271.9	0.22 μg/mL Geometric Coefficient of Variation 465.2	0.03 μg/mL Geometric Coefficient of Variation 92.1
Concentrations of IgG Antibodies Specific to the AlpN Proteins in μg/mL in Blood From Each Baby Alp1N: At 1 month of age	4.81 μg/mL Geometric Coefficient of Variation 419.4	2.92 μg/mL Geometric Coefficient of Variation 184.7	7.02 μg/mL Geometric Coefficient of Variation 116.3	1.72 μg/mL Geometric Coefficient of Variation 983.6	0.05 μg/mL Geometric Coefficient of Variation 424.7
Concentrations of IgG Antibodies Specific to the AlpN Proteins in μg/mL in Blood From Each Baby Alp1N: At 3 months of age	1.91 μg/mL Geometric Coefficient of Variation 270.3	1.24 μg/mL Geometric Coefficient of Variation 149.0	2.26 μg/mL Geometric Coefficient of Variation 152.6	0.54 μg/mL Geometric Coefficient of Variation 515.7	0.03 μg/mL Geometric Coefficient of Variation 127.2
Concentrations of IgG Antibodies Specific to the AlpN Proteins in μg/mL in Blood From Each Baby Alp2N: At 1 month of age	4.25 μg/mL Geometric Coefficient of Variation 379.8	2.87 μg/mL Geometric Coefficient of Variation 281.3	3.91 μg/mL Geometric Coefficient of Variation 283.4	1.43 μg/mL Geometric Coefficient of Variation 916.8	0.05 μg/mL Geometric Coefficient of Variation 534.0

Adverse Events

Group 1 (Mothers): 4 Week Dose Interval; 2 Doses

Serious events: 23 serious events

Other events: 56 other events

Deaths: 0 deaths

Group 2 (Mothers): Early Intervention; 4 Week Dose Interval; 2 Doses

Serious events: 12 serious events

Other events: 54 other events

Deaths: 0 deaths

Group 3 (Mothers): Early Intervention; 8 Week Dose Interval; 2 Doses

Serious events: 20 serious events

Other events: 57 other events

Deaths: 0 deaths

Group 4 (Mothers): Single Dose

Serious events: 25 serious events

Other events: 56 other events

Deaths: 0 deaths

Group 5 (Mothers): Placebo

Serious events: 14 serious events

Other events: 26 other events

Deaths: 0 deaths

Group 1 (Infants): 4 Week Dose Interval; 2 Doses

Serious events: 15 serious events

Other events: 43 other events

Deaths: 2 deaths

Group 2 (Infants): Early Intervention; 4 Week Dose Interval; 2 Doses

Serious events: 13 serious events

Other events: 38 other events

Deaths: 2 deaths

Group 3 (Infants): Early Intervention; 8 Week Dose Interval; 2 Doses

Serious events: 16 serious events

Other events: 38 other events

Deaths: 1 deaths

Group 4 (Infants): Single Dose

Serious events: 17 serious events

Other events: 45 other events

Deaths: 3 deaths

Group 5 (Infants): Placebo

Serious events: 7 serious events

Other events: 21 other events

Deaths: 1 deaths

Serious adverse events

Measure	Group 1 (Mothers): 4 Week Dose Interval; 2 Doses n=61 participants at risk Participants received one injection of placebo at 22 (±1) weeks GA (gestational age), one injection of GBS-NN/NN2 at 26 (±1) weeks GA and one injection of GBS- NN/NN2 at 30 (±1) weeks GA GBS-NN/NN2 Vaccine: 0.5 mL GBS-NN/NN2 containing 50 μg of GBS-NN and 50 μg of GBS-NN2 and 0.5 mg of aluminium, given by intramuscular injection. Placebo: 0.5 mL normal saline given by intramuscular injection	Group 2 (Mothers): Early Intervention; 4 Week Dose Interval; 2 Doses n=59 participants at risk Participants received one injection of GBS-NN/NN2 at 22 (±1) weeks GA, one injection of GBS-NN/NN2 at 26 (±1) weeks GA and one injection of placebo at 30 (±1) weeks GA GBS-NN/NN2 Vaccine: 0.5 mL GBS-NN/NN2 containing 50 μg of GBS-NN and 50 μg of GBS-NN2 and 0.5 mg of aluminium, given by intramuscular injection. Placebo: 0.5 mL normal saline given by intramuscular injection	Group 3 (Mothers): Early Intervention; 8 Week Dose Interval; 2 Doses n=59 participants at risk Participants received one injection of GBS-NN/NN2 at 22 (±1) weeks GA, one injection of placebo at 26 (±1) weeks GA and one injection of GBS- NN/NN2 at 30 (±1) weeks GA GBS-NN/NN2 Vaccine: 0.5 mL GBS-NN/NN2 containing 50 μg of GBS-NN and 50 μg of GBS-NN2 and 0.5 mg of aluminium, given by intramuscular injection. Placebo: 0.5 mL normal saline given by intramuscular injection	Group 4 (Mothers): Single Dose n=60 participants at risk Participants received one injection of placebo at 22 (±1) weeks GA, one injection of GBS-NN/NN2 at 26 (±1) weeks GA, and one injection of placebo at 30 (±1) weeks GA. GBS-NN/NN2 Vaccine: 0.5 mL GBS-NN/NN2 containing 50 μg of GBS-NN and 50 μg of GBS-NN2 and 0.5 mg of aluminium, given by intramuscular injection. Placebo: 0.5 mL normal saline given by intramuscular injection	Group 5 (Mothers): Placebo n=30 participants at risk Participants received one injection of placebo at 22, 26 and 30 weeks (±1) GA Placebo: 0.5 mL normal saline given by intramuscular injection	Group 1 (Infants): 4 Week Dose Interval; 2 Doses n=61 participants at risk Infants of participants from group 1, who received one injection of placebo at 22 (±1) weeks GA, one injection of GBS-NN/NN2 at 26 (±1) weeks GA and one injection of GBS- NN/NN2 at 30 (±1) weeks GA	Group 2 (Infants): Early Intervention; 4 Week Dose Interval; 2 Doses n=58 participants at risk Infants of participants from group 2, who received one injection of GBS-NN/NN2 at 22 (±1) weeks GA, one injection of GBS-NN/NN2 at 26 (±1) weeks GA and one injection of placebo at 30 (±1) weeks GA	Group 3 (Infants): Early Intervention; 8 Week Dose Interval; 2 Doses n=58 participants at risk Infants of participant of group 3, who received one injection of GBS-NN/NN2 at 22 (±1) weeks GA, one injection of placebo at 26 (±1) weeks GA and one injection of GBS- NN/NN2 at 30 (±1) weeks GA	Group 4 (Infants): Single Dose n=57 participants at risk Infants of participants from group 4, who received one injection of placebo at 22 (±1) weeks GA, one injection of GBS-NN/NN2 at 26 (±1) weeks GA, and one injection of placebo at 30 (±1) weeks GA	Group 5 (Infants): Placebo n=29 participants at risk Infant of participants from group 5, who received one injection of placebo at 22, 26 and 30 weeks (±1) GA
Pregnancy, puerperium and perinatal conditions Foetal distress syndrome	13.1% 8/61 • Number of events 8 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	3.4% 2/59 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	8.5% 5/59 • Number of events 5 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	20.0% 12/60 • Number of events 12 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	23.3% 7/30 • Number of events 7 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Pregnancy, puerperium and perinatal conditions Pre-eclampsia	4.9% 3/61 • Number of events 3 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	5.1% 3/59 • Number of events 3 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	3.4% 2/59 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	6.7% 4/60 • Number of events 4 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	6.7% 2/30 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Pregnancy, puerperium and perinatal conditions Gestational hypertension	3.3% 2/61 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.7% 1/59 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	6.8% 4/59 • Number of events 4 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	6.7% 4/60 • Number of events 4 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	10.0% 3/30 • Number of events 3 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Pregnancy, puerperium and perinatal conditions Prolonged labour	4.9% 3/61 • Number of events 3 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.7% 1/59 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	5.1% 3/59 • Number of events 3 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	5.0% 3/60 • Number of events 3 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	6.7% 2/30 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Infections and infestations Sepsis neonatal	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.6% 1/61 • Number of events 3 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	3.4% 2/58 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	7.0% 4/57 • Number of events 9 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	3.4% 1/29 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Pregnancy, puerperium and perinatal conditions Premature delivery	1.6% 1/61 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	5.1% 3/59 • Number of events 3 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	3.4% 2/59 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	5.0% 3/60 • Number of events 3 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	3.3% 1/30 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Pregnancy, puerperium and perinatal conditions Foetal death	3.3% 2/61 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.7% 1/59 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.7% 1/59 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	5.0% 3/60 • Number of events 3 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	3.3% 1/30 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.7% 1/58 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Infections and infestations Urinary tract infection	1.6% 1/61 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	6.8% 4/59 • Number of events 4 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	8.5% 5/59 • Number of events 5 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.7% 1/60 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	3.3% 1/30 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.6% 1/61 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Pregnancy, puerperium and perinatal conditions Foetal Growth restriction	1.6% 1/61 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.7% 1/59 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.7% 1/59 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	6.7% 4/60 • Number of events 4 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Pregnancy, puerperium and perinatal conditions HELLP syndrome	3.3% 2/61 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.7% 1/59 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	3.3% 1/30 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Pregnancy, puerperium and perinatal conditions Oligohydramnios	3.3% 2/61 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.7% 1/59 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.7% 1/60 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Pregnancy, puerperium and perinatal conditions Postpartum haemorrhage	1.6% 1/61 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	3.4% 2/59 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	3.3% 2/60 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Pregnancy, puerperium and perinatal conditions False labour	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	3.4% 2/59 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Pregnancy, puerperium and perinatal conditions Foetal hypokinesia	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	3.4% 2/59 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.7% 1/60 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Pregnancy, puerperium and perinatal conditions Gestational diabetes	3.3% 2/61 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.7% 1/60 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	3.3% 1/30 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Pregnancy, puerperium and perinatal conditions Intrapartum haemorrhage	1.6% 1/61 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.7% 1/59 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	3.3% 1/30 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Pregnancy, puerperium and perinatal conditions Placenta praevia	1.6% 1/61 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.7% 1/59 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Pregnancy, puerperium and perinatal conditions Premature labour	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	3.4% 2/59 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.7% 1/60 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Pregnancy, puerperium and perinatal conditions Premature rupture of membranes	1.6% 1/61 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.7% 1/59 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	3.3% 1/30 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	1.6% 1/61 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Pregnancy, puerperium and perinatal conditions Abortion threatened	1.6% 1/61 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Pregnancy, puerperium and perinatal conditions Amniorrhoea	1.6% 1/61 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Pregnancy, puerperium and perinatal conditions Cephalo-pelvic disproportion	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.7% 1/59 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Pregnancy, puerperium and perinatal conditions Failed induction of labour	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.7% 1/59 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	3.3% 1/30 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Pregnancy, puerperium and perinatal conditions Foetal macrosomia	1.6% 1/61 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Pregnancy, puerperium and perinatal conditions Foetal vascular malperfusion	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.7% 1/59 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Pregnancy, puerperium and perinatal conditions Large for dates baby	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.7% 1/59 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Pregnancy, puerperium and perinatal conditions Premature separation of placenta	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.7% 1/59 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.7% 1/60 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Pregnancy, puerperium and perinatal conditions Prolonged pregnancy	1.6% 1/61 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	3.3% 1/30 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Pregnancy, puerperium and perinatal conditions Prolonged rupture of membranes	1.6% 1/61 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.7% 1/60 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	3.3% 1/30 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Pregnancy, puerperium and perinatal conditions Retroplacental haematoma	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.7% 1/59 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Pregnancy, puerperium and perinatal conditions Uterine hypotonus	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.7% 1/59 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Pregnancy, puerperium and perinatal conditions Haemorrhage in pregnancy	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	3.3% 2/60 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Pregnancy, puerperium and perinatal conditions Meconium in amniotic fluid	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.7% 1/60 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Pregnancy, puerperium and perinatal conditions Placental insufficiency	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.7% 1/60 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Infections and infestations Amniotic cavity infection	1.6% 1/61 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.7% 1/59 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.7% 1/59 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	3.3% 1/30 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Infections and infestations Upper respiratory tract infection	1.6% 1/61 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.7% 1/59 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Infections and infestations Bacterial vaginosis	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.7% 1/59 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Infections and infestations Endometritis decidual	1.6% 1/61 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Infections and infestations Escherichia infection	1.6% 1/61 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Infections and infestations Gastroenteritis	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.7% 1/59 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.7% 1/60 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.7% 1/58 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Infections and infestations Lower respiratory tract infection	1.6% 1/61 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.6% 1/61 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	3.4% 2/58 • Number of events 3 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Infections and infestations Postpartum sepsis	1.6% 1/61 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Infections and infestations Pyelonephritis	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.7% 1/59 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.7% 1/58 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Infections and infestations Sepsis	1.6% 1/61 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.7% 1/58 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Infections and infestations Beta haemolytic streptococcal infection	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	3.3% 1/30 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Infections and infestations Postoperative wound infection	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	3.3% 1/30 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Infections and infestations Urinary tract infection enterococcal	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.7% 1/60 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Blood and lymphatic system disorders Anaemia	3.3% 2/61 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.7% 1/59 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.6% 1/61 • Number of events 4 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	3.4% 2/58 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Cardiac disorders Tachycardia	1.6% 1/61 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.7% 1/59 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Cardiac disorders Sinus tachycardia	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.7% 1/59 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	3.3% 1/30 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Cardiac disorders Bradycardia foetal	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	3.3% 2/60 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Cardiac disorders Palpitations	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	3.3% 1/30 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Injury, poisoning and procedural complications Perineal injury	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.7% 1/59 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Injury, poisoning and procedural complications Post procedural haemorrhage	1.6% 1/61 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Nervous system disorders Dizziness	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.7% 1/59 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Nervous system disorders Headache	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.7% 1/59 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Nervous system disorders Migraine	1.6% 1/61 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Renal and urinary disorders Acute kidney inury	1.6% 1/61 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.7% 1/59 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.6% 1/61 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.7% 1/58 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.7% 1/58 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.8% 1/57 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Reproductive system and breast disorders Vaginal discharge	1.6% 1/61 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.7% 1/59 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Vascular disorders Hypertension	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	3.4% 2/59 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Vascular disorders Hypertensive emergency	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.7% 1/59 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Gastrointestinal disorders Gastritis	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.7% 1/59 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Investigations Foetal monitoring abnormal	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.7% 1/59 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.8% 1/57 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.7% 1/59 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	3.3% 1/30 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.7% 1/58 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.7% 1/60 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Surgical and medical procedures Artificial rupture of membranes	1.6% 1/61 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Pregnancy, puerperium and perinatal conditions Jaundice neonatal	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	4.9% 3/61 • Number of events 3 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	8.6% 5/58 • Number of events 5 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	5.2% 3/58 • Number of events 3 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	10.5% 6/57 • Number of events 7 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Pregnancy, puerperium and perinatal conditions Low birth weight baby	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.6% 1/61 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	8.6% 5/58 • Number of events 5 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	5.2% 3/58 • Number of events 3 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	3.5% 2/57 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Pregnancy, puerperium and perinatal conditions Premature baby	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.6% 1/61 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	3.4% 2/58 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	3.4% 2/58 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	5.3% 3/57 • Number of events 3 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Pregnancy, puerperium and perinatal conditions Stillbirth	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	3.3% 2/61 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.7% 1/58 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	5.3% 3/57 • Number of events 3 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	3.4% 1/29 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Congenital, familial and genetic disorders Talipes	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	3.4% 2/58 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.7% 1/58 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Congenital, familial and genetic disorders Birth mark	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.7% 1/58 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	3.4% 1/29 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Congenital, familial and genetic disorders Cleft palate	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.7% 1/58 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Congenital, familial and genetic disorders Congenital skin dimples	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.7% 1/58 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Congenital, familial and genetic disorders Epidermolysis bullosa	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.7% 1/58 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Congenital, familial and genetic disorders Hydrocele	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.6% 1/61 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Congenital, familial and genetic disorders Hypospadias	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.7% 1/58 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Congenital, familial and genetic disorders Patent ductus arteriosus	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.6% 1/61 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Congenital, familial and genetic disorders Supernumerary nipple	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.7% 1/58 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Congenital, familial and genetic disorders Ventricular septal defect	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.7% 1/58 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Nervous system disorders Seizure	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	3.3% 2/61 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Congenital, familial and genetic disorders Infantile fibromatosis	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.8% 1/57 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Injury, poisoning and procedural complications Femur fracture	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.7% 1/58 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Injury, poisoning and procedural complications Bone metabolism disorder	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.6% 1/61 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.8% 1/57 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Vascular disorders Phlebitis	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.8% 1/57 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Congenital, familial and genetic disorders Congenital naevus	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.7% 1/58 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.7% 1/58 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Pregnancy, puerperium and perinatal conditions Weight decrease neonatal	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.6% 1/61 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Pregnancy, puerperium and perinatal conditions Small for dates baby	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.8% 1/57 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Infections and infestations Pneumonia	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.6% 1/61 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.7% 1/58 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Infections and infestations Bacterial infection	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.6% 1/61 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Infections and infestations COVID-19	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.7% 1/58 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Infections and infestations Fungal sepsis	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.7% 1/58 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Infections and infestations Neonatal infection	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.7% 1/58 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Infections and infestations Pulmonary tuberculosis	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.6% 1/61 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Infections and infestations Respiratory syncytial virus infection	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.6% 1/61 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	3.5% 2/57 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Infections and infestations Septic shock	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.7% 1/58 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Infections and infestations Bronchiolitis	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.8% 1/57 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Infections and infestations Lower respiratory tract infection viral	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.8% 1/57 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Infections and infestations Meningitis neonatal	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.8% 1/57 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Infections and infestations Neonatal pneumonia	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.8% 1/57 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Respiratory, thoracic and mediastinal disorders Chronic respiratory disease	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.6% 1/61 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.7% 1/58 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Respiratory, thoracic and mediastinal disorders Neonatal respiratory distress	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.6% 1/61 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.7% 1/58 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.8% 1/57 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	3.4% 1/29 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Respiratory, thoracic and mediastinal disorders Neonatal respiratory distress syndrome	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.6% 1/61 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.7% 1/58 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	3.5% 2/57 • Number of events 4 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.7% 1/58 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.7% 1/58 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Respiratory, thoracic and mediastinal disorders Transient tachypnoea of the newborn	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.7% 1/58 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Respiratory, thoracic and mediastinal disorders Apnoea	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	3.4% 1/29 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Respiratory, thoracic and mediastinal disorders Bronchopulmonary dysplasia	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	3.5% 2/57 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Respiratory, thoracic and mediastinal disorders Meconium aspiration syndrome	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	3.4% 1/29 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.8% 1/57 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Infections and infestations Upper airway obstruction	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.8% 1/57 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Metabolism and nutrition disorders Hypernatraemia	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.6% 1/61 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.7% 1/58 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Metabolism and nutrition disorders Dehydration	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.7% 1/58 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Metabolism and nutrition disorders Electrolyte imbalance	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.6% 1/61 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Metabolism and nutrition disorders Failure to thrive	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.7% 1/58 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.8% 1/57 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.6% 1/61 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.6% 1/61 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.8% 1/57 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.6% 1/61 • Number of events 3 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.8% 1/57 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Metabolism and nutrition disorders Underweight	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.7% 1/58 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.8% 1/57 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Metabolism and nutrition disorders Metabolic acidosis	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	3.5% 2/57 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Metabolism and nutrition disorders Neonatal hyperglycaemia	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.8% 1/57 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Metabolism and nutrition disorders Weight gain poor	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.8% 1/57 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.6% 1/61 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	3.3% 1/30 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Blood and lymphatic system disorders Anaemia neonatal	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	3.5% 2/57 • Number of events 6 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Blood and lymphatic system disorders Thrombocytopenia neonatal	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.8% 1/57 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Renal and urinary disorders Haematuria	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.7% 1/58 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Renal and urinary disorders Prerenal failure	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.7% 1/58 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Gastrointestinal disorders Dysphagia	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.7% 1/58 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.7% 1/58 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Gastrointestinal disorders Necrotising enterocolitis neonatal	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.6% 1/61 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.7% 1/58 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Blood and lymphatic system disorders Food protein-induced enterocolitis syndrome	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	3.4% 1/29 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Gastrointestinal disorders Ileus paralytic	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.8% 1/57 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Gastrointestinal disorders Inguinal hernia	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.8% 1/57 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Gastrointestinal disorders Necrotising colitis	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.8% 1/57 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Investigations Body height below normal	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.7% 1/58 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Investigations Tympanometry abnormal	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.6% 1/61 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Investigations Weight decreased	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.6% 1/61 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Investigations Cardiac murmur	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	3.4% 1/29 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Investigations Electrocardiogram QT prolonged	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.8% 1/57 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Nervous system disorders Intraventricular haemorrhage neonatal	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.6% 1/61 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Nervous system disorders Encephalopathy neonatal	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.8% 1/57 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Nervous system disorders Intraventricular haemorrhage	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.8% 1/57 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Cardiac disorders Cardiac failure acute	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.7% 1/58 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Eye disorders Retinopathy of prematurity	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.6% 1/61 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
General disorders Developmental regression	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.7% 1/58 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
General disorders Drug withdrawal syndrome neonatal	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.8% 1/57 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.

Other adverse events

Measure	Group 1 (Mothers): 4 Week Dose Interval; 2 Doses n=61 participants at risk Participants received one injection of placebo at 22 (±1) weeks GA (gestational age), one injection of GBS-NN/NN2 at 26 (±1) weeks GA and one injection of GBS- NN/NN2 at 30 (±1) weeks GA GBS-NN/NN2 Vaccine: 0.5 mL GBS-NN/NN2 containing 50 μg of GBS-NN and 50 μg of GBS-NN2 and 0.5 mg of aluminium, given by intramuscular injection. Placebo: 0.5 mL normal saline given by intramuscular injection	Group 2 (Mothers): Early Intervention; 4 Week Dose Interval; 2 Doses n=59 participants at risk Participants received one injection of GBS-NN/NN2 at 22 (±1) weeks GA, one injection of GBS-NN/NN2 at 26 (±1) weeks GA and one injection of placebo at 30 (±1) weeks GA GBS-NN/NN2 Vaccine: 0.5 mL GBS-NN/NN2 containing 50 μg of GBS-NN and 50 μg of GBS-NN2 and 0.5 mg of aluminium, given by intramuscular injection. Placebo: 0.5 mL normal saline given by intramuscular injection	Group 3 (Mothers): Early Intervention; 8 Week Dose Interval; 2 Doses n=59 participants at risk Participants received one injection of GBS-NN/NN2 at 22 (±1) weeks GA, one injection of placebo at 26 (±1) weeks GA and one injection of GBS- NN/NN2 at 30 (±1) weeks GA GBS-NN/NN2 Vaccine: 0.5 mL GBS-NN/NN2 containing 50 μg of GBS-NN and 50 μg of GBS-NN2 and 0.5 mg of aluminium, given by intramuscular injection. Placebo: 0.5 mL normal saline given by intramuscular injection	Group 4 (Mothers): Single Dose n=60 participants at risk Participants received one injection of placebo at 22 (±1) weeks GA, one injection of GBS-NN/NN2 at 26 (±1) weeks GA, and one injection of placebo at 30 (±1) weeks GA. GBS-NN/NN2 Vaccine: 0.5 mL GBS-NN/NN2 containing 50 μg of GBS-NN and 50 μg of GBS-NN2 and 0.5 mg of aluminium, given by intramuscular injection. Placebo: 0.5 mL normal saline given by intramuscular injection	Group 5 (Mothers): Placebo n=30 participants at risk Participants received one injection of placebo at 22, 26 and 30 weeks (±1) GA Placebo: 0.5 mL normal saline given by intramuscular injection	Group 1 (Infants): 4 Week Dose Interval; 2 Doses n=61 participants at risk Infants of participants from group 1, who received one injection of placebo at 22 (±1) weeks GA, one injection of GBS-NN/NN2 at 26 (±1) weeks GA and one injection of GBS- NN/NN2 at 30 (±1) weeks GA	Group 2 (Infants): Early Intervention; 4 Week Dose Interval; 2 Doses n=58 participants at risk Infants of participants from group 2, who received one injection of GBS-NN/NN2 at 22 (±1) weeks GA, one injection of GBS-NN/NN2 at 26 (±1) weeks GA and one injection of placebo at 30 (±1) weeks GA	Group 3 (Infants): Early Intervention; 8 Week Dose Interval; 2 Doses n=58 participants at risk Infants of participant of group 3, who received one injection of GBS-NN/NN2 at 22 (±1) weeks GA, one injection of placebo at 26 (±1) weeks GA and one injection of GBS- NN/NN2 at 30 (±1) weeks GA	Group 4 (Infants): Single Dose n=57 participants at risk Infants of participants from group 4, who received one injection of placebo at 22 (±1) weeks GA, one injection of GBS-NN/NN2 at 26 (±1) weeks GA, and one injection of placebo at 30 (±1) weeks GA	Group 5 (Infants): Placebo n=29 participants at risk Infant of participants from group 5, who received one injection of placebo at 22, 26 and 30 weeks (±1) GA
Infections and infestations Urinary tract infection	24.6% 15/61 • Number of events 17 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	22.0% 13/59 • Number of events 16 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	13.6% 8/59 • Number of events 9 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	23.3% 14/60 • Number of events 16 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	23.3% 7/30 • Number of events 8 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.6% 1/61 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Infections and infestations Upper respiratory tract infection	14.8% 9/61 • Number of events 10 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	8.5% 5/59 • Number of events 5 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	15.3% 9/59 • Number of events 9 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	10.0% 6/60 • Number of events 7 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	16.7% 5/30 • Number of events 6 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	24.6% 15/61 • Number of events 18 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	13.8% 8/58 • Number of events 8 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	19.0% 11/58 • Number of events 12 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	22.8% 13/57 • Number of events 15 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	24.1% 7/29 • Number of events 8 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Infections and infestations Gastroenteritis	1.6% 1/61 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	6.8% 4/59 • Number of events 5 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.7% 1/59 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	3.3% 2/60 • Number of events 3 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	3.3% 1/30 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.6% 1/61 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.7% 1/58 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.8% 1/57 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Infections and infestations Vulvovaginal candidiasis	4.9% 3/61 • Number of events 3 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	3.4% 2/59 • Number of events 3 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	3.4% 2/59 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	10.0% 6/60 • Number of events 6 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	10.0% 3/30 • Number of events 3 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Infections and infestations Streptococcal urinary tract infection	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	3.4% 2/59 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	5.1% 3/59 • Number of events 3 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Pregnancy, puerperium and perinatal conditions Foetal hypokinesia	6.6% 4/61 • Number of events 5 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	6.8% 4/59 • Number of events 6 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	11.9% 7/59 • Number of events 7 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	3.3% 2/60 • Number of events 4 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	10.0% 3/30 • Number of events 3 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Pregnancy, puerperium and perinatal conditions Gestational hypertension	3.3% 2/61 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	3.4% 2/59 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	6.8% 4/59 • Number of events 4 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.7% 1/60 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	6.7% 2/30 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Pregnancy, puerperium and perinatal conditions Prolonged pregnancy	1.6% 1/61 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	5.1% 3/59 • Number of events 3 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.7% 1/59 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Pregnancy, puerperium and perinatal conditions Uterine contractions during pregnancy	6.6% 4/61 • Number of events 4 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.7% 1/59 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.7% 1/59 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	5.0% 3/60 • Number of events 4 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	3.3% 1/30 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Gastrointestinal disorders Dyspepsia	3.3% 2/61 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	6.8% 4/59 • Number of events 5 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	10.2% 6/59 • Number of events 6 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	3.3% 2/60 • Number of events 3 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	3.3% 1/30 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Gastrointestinal disorders Diarrhoea	9.8% 6/61 • Number of events 7 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	3.4% 2/59 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	3.4% 2/59 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	3.3% 2/60 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	3.3% 1/30 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.7% 1/58 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	3.4% 1/29 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Gastrointestinal disorders Vomiting	1.6% 1/61 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.7% 1/59 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	5.1% 3/59 • Number of events 3 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.7% 1/60 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	3.3% 1/30 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.7% 1/58 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.8% 1/57 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Gastrointestinal disorders Abdominal pain	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	5.1% 3/59 • Number of events 3 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	5.1% 3/59 • Number of events 4 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.7% 1/60 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Gastrointestinal disorders Gastrooesophageal reflux disease	1.6% 1/61 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	3.4% 2/59 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	3.3% 2/60 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	10.0% 3/30 • Number of events 3 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.6% 1/61 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.7% 1/58 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	5.3% 3/57 • Number of events 3 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	6.9% 2/29 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Gastrointestinal disorders Nausea	1.6% 1/61 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.7% 1/59 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.7% 1/60 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	6.7% 2/30 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Nervous system disorders Headache	13.1% 8/61 • Number of events 8 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	11.9% 7/59 • Number of events 9 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	8.5% 5/59 • Number of events 5 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	6.7% 4/60 • Number of events 4 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	13.3% 4/30 • Number of events 8 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Nervous system disorders Dizziness	3.3% 2/61 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	5.1% 3/59 • Number of events 3 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	3.3% 2/60 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Investigations Blood pressure increased	4.9% 3/61 • Number of events 3 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	3.4% 2/59 • Number of events 3 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	6.8% 4/59 • Number of events 4 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.7% 1/60 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	6.7% 2/30 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Investigations Blood creatine phosphokinase increased	3.3% 2/61 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	5.1% 3/59 • Number of events 3 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.7% 1/59 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.7% 1/60 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Investigations C-reactive protein increased	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	3.4% 2/59 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	5.0% 3/60 • Number of events 3 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	3.3% 1/30 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Reproductive system and breast disorders Vaginal discharge	8.2% 5/61 • Number of events 6 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	8.5% 5/59 • Number of events 5 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	5.1% 3/59 • Number of events 5 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	6.7% 4/60 • Number of events 4 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	3.3% 1/30 • Number of events 3 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Reproductive system and breast disorders Vaginal haemorrhage	1.6% 1/61 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	6.8% 4/59 • Number of events 4 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.7% 1/60 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
General disorders Fatigue	1.6% 1/61 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	6.8% 4/59 • Number of events 4 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	3.3% 1/30 • Number of events 3 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
General disorders Influenza like illness	1.6% 1/61 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	5.1% 3/59 • Number of events 3 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	3.3% 2/60 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.6% 1/61 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.7% 1/58 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.8% 1/57 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	3.4% 1/29 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Musculoskeletal and connective tissue disorders Back pain	3.3% 2/61 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.7% 1/59 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	5.1% 3/59 • Number of events 5 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	13.3% 4/30 • Number of events 4 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Blood and lymphatic system disorders Anaemia	4.9% 3/61 • Number of events 3 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	6.8% 4/59 • Number of events 4 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	5.1% 3/59 • Number of events 3 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	3.3% 2/60 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	10.0% 3/30 • Number of events 3 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.6% 1/61 • Number of events 4 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	3.4% 2/58 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	4.9% 3/61 • Number of events 3 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.7% 1/59 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	6.8% 4/59 • Number of events 5 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	3.3% 1/30 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Skin and subcutaneous tissue disorders Rash	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.7% 1/59 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	5.1% 3/59 • Number of events 3 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.7% 1/60 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	5.2% 3/58 • Number of events 3 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.8% 1/57 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	6.9% 2/29 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Vascular disorders Hypertension	3.3% 2/61 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	6.8% 4/59 • Number of events 5 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.7% 1/60 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	10.0% 3/30 • Number of events 3 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Pregnancy, puerperium and perinatal conditions Jaundice Neonatal	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	8.2% 5/61 • Number of events 5 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	6.9% 4/58 • Number of events 4 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	8.6% 5/58 • Number of events 6 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	5.3% 3/57 • Number of events 3 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	17.2% 5/29 • Number of events 5 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Pregnancy, puerperium and perinatal conditions Low birth weight baby	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.6% 1/61 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	5.2% 3/58 • Number of events 3 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	7.0% 4/57 • Number of events 4 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	6.9% 2/29 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Pregnancy, puerperium and perinatal conditions Small for dates baby	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.7% 1/58 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	5.3% 3/57 • Number of events 3 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	3.4% 1/29 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Skin and subcutaneous tissue disorders Eczema	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	3.3% 2/61 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	5.2% 3/58 • Number of events 3 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	3.4% 2/58 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	7.0% 4/57 • Number of events 4 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Skin and subcutaneous tissue disorders Dermatitis diaper	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	6.6% 4/61 • Number of events 4 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.7% 1/58 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	5.3% 3/57 • Number of events 3 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	3.4% 1/29 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Gastrointestinal disorders Umbilical hernia	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.7% 1/59 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	5.2% 3/58 • Number of events 3 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/57 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/29 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Gastrointestinal disorders Gastroesophageal reflux disease	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.6% 1/61 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.7% 1/58 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	5.3% 3/57 • Number of events 3 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	6.9% 2/29 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Infections and infestations Oral candidiasis	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	3.3% 2/61 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	5.2% 3/58 • Number of events 3 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	3.4% 2/58 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	5.3% 3/57 • Number of events 3 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	6.9% 2/29 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Infections and infestations COVID-19	1.6% 1/61 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.7% 1/59 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	3.3% 2/60 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.6% 1/61 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	3.4% 2/58 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/58 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.8% 1/57 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	6.9% 2/29 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Respiratory, thoracic and mediastinal disorders Nasal obstruction	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	6.6% 4/61 • Number of events 4 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	5.2% 3/58 • Number of events 3 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	5.2% 3/58 • Number of events 3 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.8% 1/57 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	6.9% 2/29 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/60 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.6% 1/61 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	3.4% 2/58 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	6.9% 4/58 • Number of events 4 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	3.5% 2/57 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	6.9% 2/29 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
Respiratory, thoracic and mediastinal disorders Respiratory disorder	0.00% 0/61 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/59 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	1.7% 1/60 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	0.00% 0/30 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	3.3% 2/61 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	3.4% 2/58 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	5.2% 3/58 • Number of events 3 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	3.5% 2/57 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.	3.4% 1/29 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study. Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary. AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.

Additional Information

Cornelia Oostvogels/Chief Medical Officer (CMO)

MinervaX

Phone: 00491515092821

Email: lio@minervax.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place