Trial Outcomes & Findings for Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Boostrix™ Vaccine in Pregnant Women (NCT NCT02377349)

Last Updated: 2020-01-28

Results Overview

Antibody concentrations were assessed by Enzyme-linked immunosorbent assay (ELISA), tabulated as Geometric Mean Concentrations (GMCs) and expressed in International units per mililiter (IU/mL) for the following assay cut-offs: 2.693 IU/mL for anti-PT, 2.046 IU/mL for anti-FHA and 2.187 IU/mL for anti-PRN.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

688 participants

Primary outcome timeframe

At delivery - Visit 3 (anytime after 28 weeks of gestation)

Results posted on

2020-01-28

Participant Flow

A total of 725 pregnant subjects were screened of which 690 were randomized to 2 groups. Of these, 2 subjects were withdrawn before vaccination. Therefore 688 subjects were enrolled: 1 subject was excluded from the statistical analysis, leaving 687 subjects that comprised the Total Vaccinated cohort.

Safety was assessed for infants born to vaccinated subjects as well as safety of dTap vaccination in the vaccinated pregnant subjects. There was also an assessment of the acceptance rate of a single dose of Boostrix among 723 eligible household contacts of the infants born to pregnant women enrolled in Spain, as part of an assessment of cocooning.

Participant milestones

Participant milestones
Measure	dTpa Group - Mother This group consisted of pregnant women who received a single dose of Boostrix at 27-36 weeks (i.e. 27 weeks until 36 completed weeks) of gestation (Visit 1) and received a dose of the placebo post-delivery (within 72 hours).	Control Group - Mother This group consisted of pregnant women who received a single dose of placebo at 27-36 weeks (i.e. 27 weeks until 36 completed weeks) of gestation (Visit 1) and received a dose of Boostrix post-delivery (within 72 hours).
Overall Study STARTED	341	346
Overall Study COMPLETED	325	335
Overall Study NOT COMPLETED	16	11

Reasons for withdrawal

Reasons for withdrawal
Measure	dTpa Group - Mother This group consisted of pregnant women who received a single dose of Boostrix at 27-36 weeks (i.e. 27 weeks until 36 completed weeks) of gestation (Visit 1) and received a dose of the placebo post-delivery (within 72 hours).	Control Group - Mother This group consisted of pregnant women who received a single dose of placebo at 27-36 weeks (i.e. 27 weeks until 36 completed weeks) of gestation (Visit 1) and received a dose of Boostrix post-delivery (within 72 hours).
Overall Study Serious Adverse Event	1	0
Overall Study Protocol Violation	3	2
Overall Study Withdrawal by Subject	5	3
Overall Study Lost to follow-up (partial vaccination)	1	0
Overall Study Lost to follow-up (complete vaccination)	6	5
Overall Study Other	0	1

Baseline Characteristics

Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Boostrix™ Vaccine in Pregnant Women

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	dTpa Group - Mother n=341 Participants This group consisted of pregnant women who received a single dose of Boostrix at 27-36 weeks (i.e. 27 weeks until 36 completed weeks) of gestation (Visit 1) and received a dose of the placebo post-delivery (within 72 hours).	Control Group - Mother n=346 Participants This group consisted of pregnant women who received a single dose of placebo at 27-36 weeks (i.e. 27 weeks until 36 completed weeks) of gestation (Visit 1) and received a dose of Boostrix post-delivery (within 72 hours).	Total n=687 Participants Total of all reporting groups
Age, Continuous	32.7 Years STANDARD_DEVIATION 4.4 • n=5 Participants	32.5 Years STANDARD_DEVIATION 4.3 • n=7 Participants	32.6 Years STANDARD_DEVIATION 4.35 • n=5 Participants
Sex/Gender, Customized Female	341 Participants n=5 Participants	346 Participants n=7 Participants	687 Participants n=5 Participants
Sex/Gender, Customized Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized African Heritage / African American	3 Participants n=5 Participants	9 Participants n=7 Participants	12 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaskan Native	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Asian - Central/South Asian Heritage	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized Asian - East Asian Heritage	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized Asian - Japanese Heritage	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Asian - South East Asian Heritage	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized White - Arabic / North African Heritage	3 Participants n=5 Participants	7 Participants n=7 Participants	10 Participants n=5 Participants
Race/Ethnicity, Customized White - Caucasian / European Heritage	314 Participants n=5 Participants	319 Participants n=7 Participants	633 Participants n=5 Participants
Race/Ethnicity, Customized Unspecified	10 Participants n=5 Participants	9 Participants n=7 Participants	19 Participants n=5 Participants

PRIMARY outcome

Timeframe: At delivery - Visit 3 (anytime after 28 weeks of gestation)

Population: The analysis was done on the According to protocol cohort for immunogenicity , which included all evaluable subjects who complied with the vaccine administration, who had cord blood collected at least 21 days post-vaccination and for whom data concerning antibodies against at least 1 study vaccine antigen component at Visit 3 were available.

Outcome measures

Outcome measures
Measure	dTpa Group - Mother n=291 Participants This group consisted of pregnant women who received a single dose of Boostrix at 27-36 weeks (i.e. 27 weeks until 36 completed weeks) of gestation (Visit 1) and received a dose of the placebo post-delivery (within 72 hours).	Control Group - Mother n=292 Participants This group consisted of pregnant women who received a single dose of placebo at 27-36 weeks (i.e. 27 weeks until 36 completed weeks) of gestation (Visit 1) and received a dose of Boostrix post-delivery (within 72 hours).	dTpa Group - Infant This group consisted of infants born to mothers (from dTpa Group Mother) who received a dose of Boostrix during pregnancy.	Control Group - Infant This group consisted of infants born to mothers (from Control Group Mother) who received a dose of placebo during pregnancy	Household Group This group consisted of eligible household contacts of the infants born to pregnant women enrolled in Spain who received a single dose of Boostrix anytime during the study.
Antibody Concentrations Against Pertussis Toxoid Antigen (Anti-PT), Filamentous Haemagglutinin Antigen (Anti-FHA) and Pertactin Antigen (Anti-PRN) in Cord Blood Samples Anti-PT	46.9 IU/mL Interval 41.2 to 53.3	5.5 IU/mL Interval 4.8 to 6.3	—	—	—
Antibody Concentrations Against Pertussis Toxoid Antigen (Anti-PT), Filamentous Haemagglutinin Antigen (Anti-FHA) and Pertactin Antigen (Anti-PRN) in Cord Blood Samples Anti-FHA	366.1 IU/mL Interval 329.0 to 407.3	22.7 IU/mL Interval 19.7 to 26.2	—	—	—
Antibody Concentrations Against Pertussis Toxoid Antigen (Anti-PT), Filamentous Haemagglutinin Antigen (Anti-FHA) and Pertactin Antigen (Anti-PRN) in Cord Blood Samples Anti-PRN	301.8 IU/mL Interval 250.9 to 362.9	14.6 IU/mL Interval 12.1 to 17.7	—	—	—

SECONDARY outcome

Timeframe: From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study).

Population: This analysis was performed on the Total Vaccinated cohort (TVC) which included all subjects with the study vaccine administration documented.

Pregnancy outcomes included live birth with no congenital anomalies, live birth with congenital anomalies, still birth with no congenital anomalies, still birth with congenital anomalies, elective termination with no congenital anomalies and elective termination with congenital anomalies. No subjects with still birth or elective termination of infant were reported.

Outcome measures

Outcome measures
Measure	dTpa Group - Mother n=341 Participants This group consisted of pregnant women who received a single dose of Boostrix at 27-36 weeks (i.e. 27 weeks until 36 completed weeks) of gestation (Visit 1) and received a dose of the placebo post-delivery (within 72 hours).	Control Group - Mother n=346 Participants This group consisted of pregnant women who received a single dose of placebo at 27-36 weeks (i.e. 27 weeks until 36 completed weeks) of gestation (Visit 1) and received a dose of Boostrix post-delivery (within 72 hours).	dTpa Group - Infant This group consisted of infants born to mothers (from dTpa Group Mother) who received a dose of Boostrix during pregnancy.	Control Group - Infant This group consisted of infants born to mothers (from Control Group Mother) who received a dose of placebo during pregnancy	Household Group This group consisted of eligible household contacts of the infants born to pregnant women enrolled in Spain who received a single dose of Boostrix anytime during the study.
Percentage of Subjects by Pregnancy Outcomes Live infant No apparent congenital anomaly	97.4 Percentage of subjects Interval 95.0 to 98.8	97.4 Percentage of subjects Interval 95.1 to 98.8	—	—	—
Percentage of Subjects by Pregnancy Outcomes Live infant congenital anomaly	2.6 Percentage of subjects Interval 1.2 to 5.0	2.3 Percentage of subjects Interval 1.0 to 4.5	—	—	—
Percentage of Subjects by Pregnancy Outcomes Lost to follow-up	0 Percentage of subjects Interval 0.0 to 1.1	0.3 Percentage of subjects Interval 0.0 to 1.6	—	—	—

SECONDARY outcome

Timeframe: From Day 0 (Visit 1) to Month 2 post-delivery (Visit 4, end of the study).

Population: This analysis was performed on the TVC which included all subjects with the study vaccine administration documented.

Listed pregnancy-related adverse events of interest/ neonate-related events of interest included gestational diabetes, pregnancy-related hypertension, premature rupture of mem-branes, preterm premature rupture of membranes, premature labour, premature uterine contractions, intrauterine growth restriction/poor foetal growth, pre-eclampsia, eclampsia, vaginal or intrauterine haemorrhage, maternal death, preterm birth, neonatal death, small for gestational age, neonatal hypoxic ischaemic encephalopathy and failure to thrive/growth deficiency were reported.

Outcome measures

Outcome measures
Measure	dTpa Group - Mother n=341 Participants This group consisted of pregnant women who received a single dose of Boostrix at 27-36 weeks (i.e. 27 weeks until 36 completed weeks) of gestation (Visit 1) and received a dose of the placebo post-delivery (within 72 hours).	Control Group - Mother n=346 Participants This group consisted of pregnant women who received a single dose of placebo at 27-36 weeks (i.e. 27 weeks until 36 completed weeks) of gestation (Visit 1) and received a dose of Boostrix post-delivery (within 72 hours).	dTpa Group - Infant This group consisted of infants born to mothers (from dTpa Group Mother) who received a dose of Boostrix during pregnancy.	Control Group - Infant This group consisted of infants born to mothers (from Control Group Mother) who received a dose of placebo during pregnancy	Household Group This group consisted of eligible household contacts of the infants born to pregnant women enrolled in Spain who received a single dose of Boostrix anytime during the study.
Percentage of Subjects With Listed Pregnancy/Neonate Related Adverse Events of Interest Intrauterine growth restriction/poor foetal growth	1.5 Percentage of subjects Interval 0.5 to 3.4	0.6 Percentage of subjects Interval 0.1 to 2.1	—	—	—
Percentage of Subjects With Listed Pregnancy/Neonate Related Adverse Events of Interest Pre-eclampsia	0.3 Percentage of subjects Interval 0.0 to 1.6	1.4 Percentage of subjects Interval 0.5 to 3.3	—	—	—
Percentage of Subjects With Listed Pregnancy/Neonate Related Adverse Events of Interest Pregnancy-related hypertension	1.2 Percentage of subjects Interval 0.3 to 3.0	1.4 Percentage of subjects Interval 0.5 to 3.3	—	—	—
Percentage of Subjects With Listed Pregnancy/Neonate Related Adverse Events of Interest Premature labour	3.8 Percentage of subjects Interval 2.0 to 6.4	3.2 Percentage of subjects Interval 1.6 to 5.6	—	—	—
Percentage of Subjects With Listed Pregnancy/Neonate Related Adverse Events of Interest Premature rupture of membranes	3.8 Percentage of subjects Interval 2.0 to 6.4	4.3 Percentage of subjects Interval 2.4 to 7.0	—	—	—
Percentage of Subjects With Listed Pregnancy/Neonate Related Adverse Events of Interest Premature uterine contractions	0.6 Percentage of subjects Interval 0.1 to 2.1	0.9 Percentage of subjects Interval 0.2 to 2.5	—	—	—
Percentage of Subjects With Listed Pregnancy/Neonate Related Adverse Events of Interest Preterm birth	3.2 Percentage of subjects Interval 1.6 to 5.7	2.6 Percentage of subjects Interval 1.2 to 4.9	—	—	—
Percentage of Subjects With Listed Pregnancy/Neonate Related Adverse Events of Interest Preterm premature rupture of membranes	1.2 Percentage of subjects Interval 0.3 to 3.0	2 Percentage of subjects Interval 0.8 to 4.1	—	—	—
Percentage of Subjects With Listed Pregnancy/Neonate Related Adverse Events of Interest Small for gestational age	0.6 Percentage of subjects Interval 0.1 to 2.1	0.6 Percentage of subjects Interval 0.1 to 2.1	—	—	—
Percentage of Subjects With Listed Pregnancy/Neonate Related Adverse Events of Interest Vaginal or intrauterine haemorrhage	2.6 Percentage of subjects Interval 1.2 to 5.0	2.9 Percentage of subjects Interval 1.4 to 5.3	—	—	—

SECONDARY outcome

Timeframe: One month post vaccination (Day 30) during pregnancy

Population: The analysis was done on the According to protocol cohort for immunogenicity , which included all evaluable subjects who complied with the vaccine administration and for whom data concerning antibodies against at least 1 study vaccine antigen component at Visit 2 were available.

A seroprotected subject against diphteria and tetanus was a subject with antibody concentration ≥ 0.1 IU/mL. A seropositive subject was a subjects with antibody concentration ≥ 2.693 IU/mL for anti-PT, ≥ 2.046 IU/mL for anti-FHA and ≥ 2.187 IU/mL for anti-PRN.

Outcome measures

Outcome measures
Measure	dTpa Group - Mother n=290 Participants This group consisted of pregnant women who received a single dose of Boostrix at 27-36 weeks (i.e. 27 weeks until 36 completed weeks) of gestation (Visit 1) and received a dose of the placebo post-delivery (within 72 hours).	Control Group - Mother n=292 Participants This group consisted of pregnant women who received a single dose of placebo at 27-36 weeks (i.e. 27 weeks until 36 completed weeks) of gestation (Visit 1) and received a dose of Boostrix post-delivery (within 72 hours).	dTpa Group - Infant This group consisted of infants born to mothers (from dTpa Group Mother) who received a dose of Boostrix during pregnancy.	Control Group - Infant This group consisted of infants born to mothers (from Control Group Mother) who received a dose of placebo during pregnancy	Household Group This group consisted of eligible household contacts of the infants born to pregnant women enrolled in Spain who received a single dose of Boostrix anytime during the study.
Percentage of Seroprotected Subjects Against Diphteria Antigen (Anti-D), Tetanus Antigen (Anti-T) and of Seropositive Subjects Against Anti-PT, Anti-FHA and Anti-PRN Anti-D	97.6 Percentage of subjects Interval 95.1 to 99.0	70.6 Percentage of subjects Interval 65.0 to 75.8	—	—	—
Percentage of Seroprotected Subjects Against Diphteria Antigen (Anti-D), Tetanus Antigen (Anti-T) and of Seropositive Subjects Against Anti-PT, Anti-FHA and Anti-PRN Anti-T	100 Percentage of subjects Interval 98.7 to 100.0	96.6 Percentage of subjects Interval 93.8 to 98.3	—	—	—
Percentage of Seroprotected Subjects Against Diphteria Antigen (Anti-D), Tetanus Antigen (Anti-T) and of Seropositive Subjects Against Anti-PT, Anti-FHA and Anti-PRN Anti-PT	98.6 Percentage of subjects Interval 96.5 to 99.6	61.3 Percentage of subjects Interval 55.5 to 66.9	—	—	—
Percentage of Seroprotected Subjects Against Diphteria Antigen (Anti-D), Tetanus Antigen (Anti-T) and of Seropositive Subjects Against Anti-PT, Anti-FHA and Anti-PRN Anti-FHA	100 Percentage of subjects Interval 98.7 to 100.0	94.5 Percentage of subjects Interval 91.2 to 96.8	—	—	—
Percentage of Seroprotected Subjects Against Diphteria Antigen (Anti-D), Tetanus Antigen (Anti-T) and of Seropositive Subjects Against Anti-PT, Anti-FHA and Anti-PRN Anti-PRN	100 Percentage of subjects Interval 98.7 to 100.0	84.5 Percentage of subjects Interval 79.9 to 88.5	—	—	—

SECONDARY outcome

Timeframe: One month post vaccination (Day 30) during pregnancy

Antibody concentrations were determined by ELISA, tabulated as GMCs and expressed in IU/mL.

Outcome measures

Outcome measures
Measure	dTpa Group - Mother n=290 Participants This group consisted of pregnant women who received a single dose of Boostrix at 27-36 weeks (i.e. 27 weeks until 36 completed weeks) of gestation (Visit 1) and received a dose of the placebo post-delivery (within 72 hours).	Control Group - Mother n=292 Participants This group consisted of pregnant women who received a single dose of placebo at 27-36 weeks (i.e. 27 weeks until 36 completed weeks) of gestation (Visit 1) and received a dose of Boostrix post-delivery (within 72 hours).	dTpa Group - Infant This group consisted of infants born to mothers (from dTpa Group Mother) who received a dose of Boostrix during pregnancy.	Control Group - Infant This group consisted of infants born to mothers (from Control Group Mother) who received a dose of placebo during pregnancy	Household Group This group consisted of eligible household contacts of the infants born to pregnant women enrolled in Spain who received a single dose of Boostrix anytime during the study.
Anti-D, Anti-T, Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Anti-PRN	283.6 IU/mL Interval 237.1 to 339.1	10.5 IU/mL Interval 8.7 to 12.5	—	—	—
Anti-D, Anti-T, Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Anti-D	2.19 IU/mL Interval 1.87 to 2.57	0.23 IU/mL Interval 0.19 to 0.27	—	—	—
Anti-D, Anti-T, Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Anti-T	8.43 IU/mL Interval 7.72 to 9.2	0.98 IU/mL Interval 0.86 to 1.11	—	—	—
Anti-D, Anti-T, Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Anti-PT	45.6 IU/mL Interval 40.4 to 51.5	4.1 IU/mL Interval 3.6 to 4.6	—	—	—
Anti-D, Anti-T, Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Anti-FHA	317.5 IU/mL Interval 285.0 to 353.8	15 IU/mL Interval 13.1 to 17.2	—	—	—

SECONDARY outcome

Timeframe: One month post vaccination (Day 30) during pregnancy

Vaccine response for anti-D and anti-T was defined as: for initially seronegative subjects (S-) with pre-vaccination concentration below cut-off: \< 0.1 IU/mL) was an antibody concentration at least four times the assay cut-off (post-vaccination concentration ≥ 0.4 IU/mL); for initially seropositive subjects (S+) with pre-vaccination concentration ≥ 0.1 IU/mL): an increase in antibody concentrations of at least four times the pre-vaccination concentration.

Outcome measures

Outcome measures
Measure	dTpa Group - Mother n=288 Participants This group consisted of pregnant women who received a single dose of Boostrix at 27-36 weeks (i.e. 27 weeks until 36 completed weeks) of gestation (Visit 1) and received a dose of the placebo post-delivery (within 72 hours).	Control Group - Mother n=291 Participants This group consisted of pregnant women who received a single dose of placebo at 27-36 weeks (i.e. 27 weeks until 36 completed weeks) of gestation (Visit 1) and received a dose of Boostrix post-delivery (within 72 hours).	dTpa Group - Infant This group consisted of infants born to mothers (from dTpa Group Mother) who received a dose of Boostrix during pregnancy.	Control Group - Infant This group consisted of infants born to mothers (from Control Group Mother) who received a dose of placebo during pregnancy	Household Group This group consisted of eligible household contacts of the infants born to pregnant women enrolled in Spain who received a single dose of Boostrix anytime during the study.
Percentage of Subjects With Vaccine Response to Anti-D and Anti-T Anti-D, S-	64.1 Percentage of subjects Interval 54.0 to 73.3	0 Percentage of subjects Interval 0.0 to 4.3	—	—	—
Percentage of Subjects With Vaccine Response to Anti-D and Anti-T Anti-D, S+	75 Percentage of subjects Interval 68.1 to 81.1	0 Percentage of subjects Interval 0.0 to 1.8	—	—	—
Percentage of Subjects With Vaccine Response to Anti-D and Anti-T Anti-D, Total	71.1 Percentage of subjects Interval 65.5 to 76.3	0 Percentage of subjects Interval 0.0 to 1.3	—	—	—
Percentage of Subjects With Vaccine Response to Anti-D and Anti-T Anti-T, S-	100 Percentage of subjects Interval 73.5 to 100.0	0 Percentage of subjects Interval 0.0 to 30.8	—	—	—
Percentage of Subjects With Vaccine Response to Anti-D and Anti-T Anti-T, S+	67.8 Percentage of subjects Interval 61.9 to 73.2	0 Percentage of subjects Interval 0.0 to 1.3	—	—	—
Percentage of Subjects With Vaccine Response to Anti-D and Anti-T Anti-T, Total	69.1 Percentage of subjects Interval 63.4 to 74.4	0 Percentage of subjects Interval 0.0 to 1.3	—	—	—

SECONDARY outcome

Timeframe: One month post vaccination (Day 30) during pregnancy

Vaccine response to PT, FHA and PRN antigens is defined as: for subjects with pre-vaccination antibody concentration below the assay cut-off (S-), post-vaccination anti-body concentration ≥ 4 times the assay cut-off; for subjects with pre-vaccination antibody concentration between the assay cut-off and below 4 times the assay cut-off (S+), post-vaccination antibody concentration ≥ 4 times the pre-vaccination antibody concentration, and for subjects with pre-vaccination antibody concentration ≥4 times the assay cut-off (S+), post-vaccination antibody concentration ≥2 times the pre-vaccination antibody concentration.

Outcome measures

Outcome measures
Measure	dTpa Group - Mother n=288 Participants This group consisted of pregnant women who received a single dose of Boostrix at 27-36 weeks (i.e. 27 weeks until 36 completed weeks) of gestation (Visit 1) and received a dose of the placebo post-delivery (within 72 hours).	Control Group - Mother n=291 Participants This group consisted of pregnant women who received a single dose of placebo at 27-36 weeks (i.e. 27 weeks until 36 completed weeks) of gestation (Visit 1) and received a dose of Boostrix post-delivery (within 72 hours).	dTpa Group - Infant This group consisted of infants born to mothers (from dTpa Group Mother) who received a dose of Boostrix during pregnancy.	Control Group - Infant This group consisted of infants born to mothers (from Control Group Mother) who received a dose of placebo during pregnancy	Household Group This group consisted of eligible household contacts of the infants born to pregnant women enrolled in Spain who received a single dose of Boostrix anytime during the study.
Percentage of Subjects With Vaccine Response to Anti-PT, Anti-FHA and Anti-PRN Anti-PT, S-	82.6 Percentage of subjects Interval 74.7 to 88.9	0.9 Percentage of subjects Interval 0.0 to 5.1	—	—	—
Percentage of Subjects With Vaccine Response to Anti-PT, Anti-FHA and Anti-PRN Anti-PT, S+ (<4 cut-off)	90.7 Percentage of subjects Interval 83.6 to 95.5	0 Percentage of subjects Interval 0.0 to 3.1	—	—	—
Percentage of Subjects With Vaccine Response to Anti-PT, Anti-FHA and Anti-PRN Anti-PT, S+ (≥4 cut-off)	93.1 Percentage of subjects Interval 83.3 to 98.1	3 Percentage of subjects Interval 0.4 to 10.4	—	—	—
Percentage of Subjects With Vaccine Response to Anti-PT, Anti-FHA and Anti-PRN Anti-PT, Total	87.8 Percentage of subjects Interval 83.4 to 91.4	1 Percentage of subjects Interval 0.2 to 3.0	—	—	—
Percentage of Subjects With Vaccine Response to Anti-PT, Anti-FHA and Anti-PRN Anti-FHA, S-	100 Percentage of subjects Interval 79.4 to 100.0	0 Percentage of subjects Interval 0.0 to 20.6	—	—	—
Percentage of Subjects With Vaccine Response to Anti-PT, Anti-FHA and Anti-PRN Anti-FHA, S+ (<4 cut-off)	100 Percentage of subjects Interval 95.7 to 100.0	0 Percentage of subjects Interval 0.0 to 5.5	—	—	—
Percentage of Subjects With Vaccine Response to Anti-PT, Anti-FHA and Anti-PRN Anti-FHA, S+ (≥4 cut-off)	89.9 Percentage of subjects Interval 84.7 to 93.8	1.9 Percentage of subjects Interval 0.5 to 4.8	—	—	—
Percentage of Subjects With Vaccine Response to Anti-PT, Anti-FHA and Anti-PRN Anti-FHA, Total	93.4 Percentage of subjects Interval 89.9 to 96.0	1.4 Percentage of subjects Interval 0.4 to 3.5	—	—	—
Percentage of Subjects With Vaccine Response to Anti-PT, Anti-FHA and Anti-PRN Anti-PRN, S-	86.7 Percentage of subjects Interval 73.2 to 94.9	0 Percentage of subjects Interval 0.0 to 8.2	—	—	—
Percentage of Subjects With Vaccine Response to Anti-PT, Anti-FHA and Anti-PRN Anti-PRN, S+ (<4 cut-off)	95.9 Percentage of subjects Interval 89.9 to 98.9	0 Percentage of subjects Interval 0.0 to 4.2	—	—	—
Percentage of Subjects With Vaccine Response to Anti-PT, Anti-FHA and Anti-PRN Anti-PRN, S+ (≥4 cut-off)	86.2 Percentage of subjects Interval 79.5 to 91.4	1.2 Percentage of subjects Interval 0.2 to 4.4	—	—	—
Percentage of Subjects With Vaccine Response to Anti-PT, Anti-FHA and Anti-PRN Anti-PRN Total	89.6 Percentage of subjects Interval 85.5 to 92.9	0.7 Percentage of subjects Interval 0.1 to 2.5	—	—	—

SECONDARY outcome

Timeframe: At delivery - Visit 3 (anytime after 27 eligible weeks of gestation)

For this assay the anti-PT, anti-FHA and anti-PRN seropositivity status was determined from the cord blood samples. The seropositivity cut-offs were the following: 2.693 IU/mL for anti-PT, 2.046 IU/mL for anti-FHA and 2.187 IU/mL for anti-PRN.

Outcome measures

Outcome measures
Measure	dTpa Group - Mother n=291 Participants This group consisted of pregnant women who received a single dose of Boostrix at 27-36 weeks (i.e. 27 weeks until 36 completed weeks) of gestation (Visit 1) and received a dose of the placebo post-delivery (within 72 hours).	Control Group - Mother n=292 Participants This group consisted of pregnant women who received a single dose of placebo at 27-36 weeks (i.e. 27 weeks until 36 completed weeks) of gestation (Visit 1) and received a dose of Boostrix post-delivery (within 72 hours).	dTpa Group - Infant This group consisted of infants born to mothers (from dTpa Group Mother) who received a dose of Boostrix during pregnancy.	Control Group - Infant This group consisted of infants born to mothers (from Control Group Mother) who received a dose of placebo during pregnancy	Household Group This group consisted of eligible household contacts of the infants born to pregnant women enrolled in Spain who received a single dose of Boostrix anytime during the study.
Percentage of Seropositive Subjects Against Anti-PT, Anti-FHA and Anti-PRN in the Cord Blood Samples Anti-PT	98.6 Percentage of subjects Interval 96.5 to 99.6	68.8 Percentage of subjects Interval 63.2 to 74.1	—	—	—
Percentage of Seropositive Subjects Against Anti-PT, Anti-FHA and Anti-PRN in the Cord Blood Samples Anti-FHA	100 Percentage of subjects Interval 98.7 to 100.0	96.6 Percentage of subjects Interval 93.8 to 98.3	—	—	—
Percentage of Seropositive Subjects Against Anti-PT, Anti-FHA and Anti-PRN in the Cord Blood Samples Anti-PRN	99.7 Percentage of subjects Interval 98.1 to 100.0	88 Percentage of subjects Interval 83.7 to 91.5	—	—	—

SECONDARY outcome

Timeframe: During the 8-day (Day 0-Day 7) follow-up period after vaccination during pregnancy

Population: The analysis was done on the TVC, which included all subjects with the study vaccine administration documented and who had returned their diary cards.

Assessed solicited local symptoms were pain, redness and swelling. "Any" = any report of the specified symptom irrespective of intensity grade. Dose 1 = pregnancy dose at Day 0 - Visit 1, Dose 2 = post-delivery dose at birth - Visit 3.

Outcome measures

Outcome measures
Measure	dTpa Group - Mother n=335 Participants This group consisted of pregnant women who received a single dose of Boostrix at 27-36 weeks (i.e. 27 weeks until 36 completed weeks) of gestation (Visit 1) and received a dose of the placebo post-delivery (within 72 hours).	Control Group - Mother n=343 Participants This group consisted of pregnant women who received a single dose of placebo at 27-36 weeks (i.e. 27 weeks until 36 completed weeks) of gestation (Visit 1) and received a dose of Boostrix post-delivery (within 72 hours).	dTpa Group - Infant This group consisted of infants born to mothers (from dTpa Group Mother) who received a dose of Boostrix during pregnancy.	Control Group - Infant This group consisted of infants born to mothers (from Control Group Mother) who received a dose of placebo during pregnancy	Household Group This group consisted of eligible household contacts of the infants born to pregnant women enrolled in Spain who received a single dose of Boostrix anytime during the study.
Percentage of Subjects With Solicited Local Adverse Events (AEs) Any Pain, Dose 1	86.3 Percentage of subjects Interval 82.1 to 89.8	14.6 Percentage of subjects Interval 11.0 to 18.8	—	—	—
Percentage of Subjects With Solicited Local Adverse Events (AEs) Any Redness (mm), Dose 1	28.7 Percentage of subjects Interval 23.9 to 33.8	12.8 Percentage of subjects Interval 9.5 to 16.8	—	—	—
Percentage of Subjects With Solicited Local Adverse Events (AEs) Any Swelling (mm), Dose 1	25.1 Percentage of subjects Interval 20.5 to 30.1	3.5 Percentage of subjects Interval 1.8 to 6.0	—	—	—
Percentage of Subjects With Solicited Local Adverse Events (AEs) Any Pain, Dose 2	12.7 Percentage of subjects Interval 9.2 to 16.8	62.7 Percentage of subjects Interval 57.3 to 68.0	—	—	—
Percentage of Subjects With Solicited Local Adverse Events (AEs) Any Redness (mm), Dose 2	10.5 Percentage of subjects Interval 7.4 to 14.4	29.7 Percentage of subjects Interval 24.8 to 34.9	—	—	—
Percentage of Subjects With Solicited Local Adverse Events (AEs) Any Swelling (mm), Dose 2	5.2 Percentage of subjects Interval 3.1 to 8.3	26.4 Percentage of subjects Interval 21.7 to 31.5	—	—	—

SECONDARY outcome

Timeframe: During the 8-day (Day 0-Day 7) follow-up period after vaccination during pregnancy

Population: The analysis was done on the TVC, which included all subjects with the study vaccine administration documented and who had returned their diary cards.

Assessed solicited general symptoms were fatigue, gastrointestinal symptoms (nausea, vomiting, diarrhoea and/or abdominal pain), headache and fever \[defined as oral, axillary or tympanic temperature ≥ 37.5 degrees Celsius (°C) or rectal temperature ≥ 38.0 °C\]. "Any" = any report of the specified symptom irrespective of intensity grade. Dose 1 = pregnancy dose at Day 0 - Visit 1, Dose 2 = post-delivery dose at birth - Visit 3.

Outcome measures

Outcome measures
Measure	dTpa Group - Mother n=335 Participants This group consisted of pregnant women who received a single dose of Boostrix at 27-36 weeks (i.e. 27 weeks until 36 completed weeks) of gestation (Visit 1) and received a dose of the placebo post-delivery (within 72 hours).	Control Group - Mother n=342 Participants This group consisted of pregnant women who received a single dose of placebo at 27-36 weeks (i.e. 27 weeks until 36 completed weeks) of gestation (Visit 1) and received a dose of Boostrix post-delivery (within 72 hours).	dTpa Group - Infant This group consisted of infants born to mothers (from dTpa Group Mother) who received a dose of Boostrix during pregnancy.	Control Group - Infant This group consisted of infants born to mothers (from Control Group Mother) who received a dose of placebo during pregnancy	Household Group This group consisted of eligible household contacts of the infants born to pregnant women enrolled in Spain who received a single dose of Boostrix anytime during the study.
Percentage of Subjects With Solicited General AEs Any Fatigue, Dose 1	43.6 Percentage of subjects Interval 38.2 to 49.1	36.3 Percentage of subjects Interval 31.2 to 41.6	—	—	—
Percentage of Subjects With Solicited General AEs Any Gastrointestinal symptom, Dose 1	17.9 Percentage of subjects Interval 14.0 to 22.4	15.2 Percentage of subjects Interval 11.6 to 19.5	—	—	—
Percentage of Subjects With Solicited General AEs Any Headache, Dose 1	24.8 Percentage of subjects Interval 20.2 to 29.8	22.8 Percentage of subjects Interval 18.5 to 27.6	—	—	—
Percentage of Subjects With Solicited General AEs Any Temperature/(Axillary) (°C), Dose 1	1.2 Percentage of subjects Interval 0.3 to 3.0	0.9 Percentage of subjects Interval 0.2 to 2.5	—	—	—
Percentage of Subjects With Solicited General AEs Any Fatigue, Dose 2	40.1 Percentage of subjects Interval 34.7 to 45.7	46.2 Percentage of subjects Interval 40.8 to 51.8	—	—	—
Percentage of Subjects With Solicited General AEs Any Gastrointestinal symptom, Dose 2	9.9 Percentage of subjects Interval 6.9 to 13.7	12.7 Percentage of subjects Interval 9.3 to 16.8	—	—	—
Percentage of Subjects With Solicited General AEs Any Headache, Dose 2	23.1 Percentage of subjects Interval 18.7 to 28.1	23.6 Percentage of subjects Interval 19.1 to 28.5	—	—	—
Percentage of Subjects With Solicited General AEs Any Temperature/(Axillary) (°C), Dose 2	4.6 Percentage of subjects Interval 2.6 to 7.5	9.1 Percentage of subjects Interval 6.2 to 12.7	—	—	—

SECONDARY outcome

Timeframe: Within 31 days (Day 0 - Day 30) after each vaccination

Population: The analysis was done on the TVC, which included all subjects with the study vaccine administration documented and who had returned their diary cards.

An unsolicited AE was any AE that was not solicited using a subject diary and that was spontaneously communicated by the subject. Also any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event. Dose 1 = pregnancy dose at Day 0 - Visit 1, Dose 2 = post-delivery dose at birth - Visit 3.

Outcome measures

Outcome measures
Measure	dTpa Group - Mother n=341 Participants This group consisted of pregnant women who received a single dose of Boostrix at 27-36 weeks (i.e. 27 weeks until 36 completed weeks) of gestation (Visit 1) and received a dose of the placebo post-delivery (within 72 hours).	Control Group - Mother n=346 Participants This group consisted of pregnant women who received a single dose of placebo at 27-36 weeks (i.e. 27 weeks until 36 completed weeks) of gestation (Visit 1) and received a dose of Boostrix post-delivery (within 72 hours).	dTpa Group - Infant This group consisted of infants born to mothers (from dTpa Group Mother) who received a dose of Boostrix during pregnancy.	Control Group - Infant This group consisted of infants born to mothers (from Control Group Mother) who received a dose of placebo during pregnancy	Household Group This group consisted of eligible household contacts of the infants born to pregnant women enrolled in Spain who received a single dose of Boostrix anytime during the study.
Percentage of Subjects With Unsolicited AEs Any unsolicited AE, Dose 1	38.7 Percentage of subjects Interval 33.5 to 44.1	35.5 Percentage of subjects Interval 30.5 to 40.8	—	—	—
Percentage of Subjects With Unsolicited AEs Any unsolicited AE, Dose 2	30.7 Percentage of subjects Interval 25.8 to 35.9	32.2 Percentage of subjects Interval 27.2 to 37.4	—	—	—

SECONDARY outcome

Timeframe: From delivery to Month 2 post delivery (Visit 4, end of the study).

Population: The analysis was done on the TVC of Mother, which included all subjects with the study vaccine administration documented and who had returned their diary cards.

Outcome measures

Outcome measures
Measure	dTpa Group - Mother n=341 Participants This group consisted of pregnant women who received a single dose of Boostrix at 27-36 weeks (i.e. 27 weeks until 36 completed weeks) of gestation (Visit 1) and received a dose of the placebo post-delivery (within 72 hours).	Control Group - Mother n=346 Participants This group consisted of pregnant women who received a single dose of placebo at 27-36 weeks (i.e. 27 weeks until 36 completed weeks) of gestation (Visit 1) and received a dose of Boostrix post-delivery (within 72 hours).	dTpa Group - Infant This group consisted of infants born to mothers (from dTpa Group Mother) who received a dose of Boostrix during pregnancy.	Control Group - Infant This group consisted of infants born to mothers (from Control Group Mother) who received a dose of placebo during pregnancy	Household Group This group consisted of eligible household contacts of the infants born to pregnant women enrolled in Spain who received a single dose of Boostrix anytime during the study.
Percentage of Infants With Unsolicited AEs	26.4 Percentage of subjects Interval 21.8 to 31.4	22.3 Percentage of subjects Interval 18.0 to 27.0	—	—	—

SECONDARY outcome

Timeframe: From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study).

Population: The analysis was done on the TVC, which included all subjects with the study vaccine administration documented.

A SAE was any untoward medical occurrence that resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or a congenital anomaly/birth defect in the offspring of a study subject.

Outcome measures

Outcome measures
Measure	dTpa Group - Mother n=341 Participants This group consisted of pregnant women who received a single dose of Boostrix at 27-36 weeks (i.e. 27 weeks until 36 completed weeks) of gestation (Visit 1) and received a dose of the placebo post-delivery (within 72 hours).	Control Group - Mother n=346 Participants This group consisted of pregnant women who received a single dose of placebo at 27-36 weeks (i.e. 27 weeks until 36 completed weeks) of gestation (Visit 1) and received a dose of Boostrix post-delivery (within 72 hours).	dTpa Group - Infant n=341 Participants This group consisted of infants born to mothers (from dTpa Group Mother) who received a dose of Boostrix during pregnancy.	Control Group - Infant n=346 Participants This group consisted of infants born to mothers (from Control Group Mother) who received a dose of placebo during pregnancy	Household Group n=608 Participants This group consisted of eligible household contacts of the infants born to pregnant women enrolled in Spain who received a single dose of Boostrix anytime during the study.
Number of Subjects With Serious AEs (SAEs)	51 Participants	52 Participants	52 Participants	45 Participants	0 Participants

SECONDARY outcome

Timeframe: From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study).

Population: This analysis was done on the Total cohort for household contacts in Spain, which included all eligible household contacts of the infants born to pregnant women vaccinated in Spain.

This analysis assessed the vaccination status of the household contacts (who accepted, received or refused vaccination) and also the reasons for refusal (not coming to site, refused to be vaccinated, unspecified) as part of an assessment of cocooning among the eligible household contacts.

Outcome measures

Outcome measures
Measure	dTpa Group - Mother n=723 Participants This group consisted of pregnant women who received a single dose of Boostrix at 27-36 weeks (i.e. 27 weeks until 36 completed weeks) of gestation (Visit 1) and received a dose of the placebo post-delivery (within 72 hours).	Control Group - Mother This group consisted of pregnant women who received a single dose of placebo at 27-36 weeks (i.e. 27 weeks until 36 completed weeks) of gestation (Visit 1) and received a dose of Boostrix post-delivery (within 72 hours).	dTpa Group - Infant This group consisted of infants born to mothers (from dTpa Group Mother) who received a dose of Boostrix during pregnancy.	Control Group - Infant This group consisted of infants born to mothers (from Control Group Mother) who received a dose of placebo during pregnancy	Household Group This group consisted of eligible household contacts of the infants born to pregnant women enrolled in Spain who received a single dose of Boostrix anytime during the study.
Percentage of Household Contacts of the Infants Born to Pregnant Women Vaccinated in Spain Accepted vaccination	84.4 Percentage of household contacts Interval 81.5 to 86.9	—	—	—	—
Percentage of Household Contacts of the Infants Born to Pregnant Women Vaccinated in Spain Received vaccination	84.1 Percentage of household contacts Interval 81.2 to 86.7	—	—	—	—
Percentage of Household Contacts of the Infants Born to Pregnant Women Vaccinated in Spain Refused vaccination	15.6 Percentage of household contacts Interval 13.1 to 18.5	—	—	—	—
Percentage of Household Contacts of the Infants Born to Pregnant Women Vaccinated in Spain Not coming to site	1.4 Percentage of household contacts Interval 0.7 to 2.5	—	—	—	—
Percentage of Household Contacts of the Infants Born to Pregnant Women Vaccinated in Spain Refused to be vaccinated	13.4 Percentage of household contacts Interval 11.0 to 16.1	—	—	—	—
Percentage of Household Contacts of the Infants Born to Pregnant Women Vaccinated in Spain Unspecified	0.8 Percentage of household contacts Interval 0.3 to 1.8	—	—	—	—

SECONDARY outcome

Timeframe: During the 31-day (Days 0-30) follow-up period post-vaccination (Boostrix administered preferably 2 weeks before the birth of the infant, Visit 3).

Population: This analysis was done on the Total cohort for household contacts which included all eligible household contacts of the infants born to pregnant women vaccinated in Spain. For the analysis of safety, all vaccinated household contacts are considered.

SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.

Outcome measures

Outcome measures
Measure	dTpa Group - Mother n=723 Participants This group consisted of pregnant women who received a single dose of Boostrix at 27-36 weeks (i.e. 27 weeks until 36 completed weeks) of gestation (Visit 1) and received a dose of the placebo post-delivery (within 72 hours).	Control Group - Mother This group consisted of pregnant women who received a single dose of placebo at 27-36 weeks (i.e. 27 weeks until 36 completed weeks) of gestation (Visit 1) and received a dose of Boostrix post-delivery (within 72 hours).	dTpa Group - Infant This group consisted of infants born to mothers (from dTpa Group Mother) who received a dose of Boostrix during pregnancy.	Control Group - Infant This group consisted of infants born to mothers (from Control Group Mother) who received a dose of placebo during pregnancy	Household Group This group consisted of eligible household contacts of the infants born to pregnant women enrolled in Spain who received a single dose of Boostrix anytime during the study.
Percentage of Household Contacts With SAEs	0 Percentage of subjects	—	—	—	—

Adverse Events

dTpa Group-Mother

Serious events: 51 serious events

Other events: 321 other events

Deaths: 0 deaths

Control Group-Mother

Serious events: 52 serious events

Other events: 303 other events

Deaths: 0 deaths

dTpa Group - Infant

Serious events: 52 serious events

Other events: 33 other events

Deaths: 0 deaths

Control Group-Infant

Serious events: 45 serious events

Other events: 29 other events

Deaths: 0 deaths

Household Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	dTpa Group-Mother n=341 participants at risk This group consisted of pregnant women who received a single dose of Boostrix at 27-36 weeks (i.e. completed 27 weeks until 36 weeks) of gestation (Visit 1) and received a dose of the placebo post-delivery (within 72 hours).	Control Group-Mother n=346 participants at risk This group consisted of pregnant women who received a single dose of placebo at 27-36 weeks (i.e. completed 27 weeks until 36 weeks) of gestation (Visit 1) and received a dose of Boostrix post-delivery (within 72 hours).	dTpa Group - Infant n=341 participants at risk This group consisted of infants born to mothers (from dTpa Group Mother) who received a dose of Boostrix during pregnancy.	Control Group-Infant n=346 participants at risk This group consisted of infants born to mothers (from Control Group Mother) who received a dose of placebo during pregnancy	Household Group n=608 participants at risk This group consisted of eligible household contacts of the infants born to pregnant women enrolled in Spain who received a single dose of Boostrix anytime during the study.
Blood and lymphatic system disorders Anaemia neonatal	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Blood and lymphatic system disorders Isoimmune haemolytic disease	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/341 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Cardiac disorders Atrioventricular block complete	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Cardiac disorders Supraventricular tachycardia	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/341 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Congenital, familial and genetic disorders Atrial septal defect	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/341 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Congenital, familial and genetic disorders Cardiac septal defect	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/341 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Congenital, familial and genetic disorders Congenital cardiovascular anomaly	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/341 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Congenital, familial and genetic disorders Congenital hydronephrosis	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Congenital, familial and genetic disorders Cryptorchism	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.87% 3/346 • Number of events 3 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Congenital, familial and genetic disorders Hypospadias	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Congenital, familial and genetic disorders Microtia	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/341 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Congenital, familial and genetic disorders Polydactyly	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.59% 2/341 • Number of events 2 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Congenital, familial and genetic disorders Pyloric stenosis	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/341 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Congenital, familial and genetic disorders Syndactyly	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/341 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Congenital, familial and genetic disorders Transposition of the great vessels	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Congenital, familial and genetic disorders Trisomy 21	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/341 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Congenital, familial and genetic disorders Ventricular septal defect	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/341 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/341 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Gastrointestinal disorders Vomiting	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.59% 2/341 • Number of events 2 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
General disorders Pyrexia	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/341 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.88% 3/341 • Number of events 3 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Hepatobiliary disorders Hyperbilirubinaemia neonatal	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Hepatobiliary disorders Jaundice	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	2.3% 8/341 • Number of events 8 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	1.7% 6/346 • Number of events 6 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Infections and infestations Amniotic cavity infection	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.58% 2/346 • Number of events 2 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Infections and infestations Beta haemolytic streptococcal infection	0.29% 1/341 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Infections and infestations Bronchiolitis	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.88% 3/341 • Number of events 3 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.58% 2/346 • Number of events 2 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Infections and infestations Endometritis decidual	0.59% 2/341 • Number of events 2 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Infections and infestations Enterovirus infection	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Infections and infestations Gastroenteritis	0.59% 2/341 • Number of events 2 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Infections and infestations Influenza	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/341 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Infections and infestations Mastitis	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Infections and infestations Nasopharyngitis	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Infections and infestations Neonatal infection	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.59% 2/341 • Number of events 2 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Infections and infestations Perineal infection	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Infections and infestations Pneumonia	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/341 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Infections and infestations Respiratory syncytial virus bronchiolitis	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.59% 2/341 • Number of events 2 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Infections and infestations Sepsis	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/341 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Infections and infestations Sepsis neonatal	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.58% 2/346 • Number of events 2 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Infections and infestations Superinfection bacterial	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/341 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Infections and infestations Tracheitis	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Infections and infestations Upper respiratory tract infection	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/341 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Infections and infestations Urinary tract infection	0.29% 1/341 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.59% 2/341 • Number of events 2 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Injury, poisoning and procedural complications Fall	0.29% 1/341 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Injury, poisoning and procedural complications Procedural haemorrhage	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Investigations Cardiac murmur	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Metabolism and nutrition disorders Dehydration	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.59% 2/341 • Number of events 2 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Metabolism and nutrition disorders Hypernatraemia	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/341 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.59% 2/341 • Number of events 2 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.59% 2/341 • Number of events 2 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.58% 2/346 • Number of events 2 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Metabolism and nutrition disorders Hypoglycaemia neonatal	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Metabolism and nutrition disorders Neonatal hypocalcaemia	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Nervous system disorders Hypotonia	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/341 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Nervous system disorders Somnolence neonatal	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/341 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Pregnancy, puerperium and perinatal conditions Cephalhaematoma	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.59% 2/341 • Number of events 2 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Pregnancy, puerperium and perinatal conditions Foetal distress syndrome	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.58% 2/346 • Number of events 2 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Pregnancy, puerperium and perinatal conditions Foetal growth restriction	0.88% 3/341 • Number of events 3 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/341 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Pregnancy, puerperium and perinatal conditions Gestational hypertension	1.2% 4/341 • Number of events 4 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	1.2% 4/346 • Number of events 4 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Pregnancy, puerperium and perinatal conditions Hellp syndrome	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.58% 2/346 • Number of events 2 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Pregnancy, puerperium and perinatal conditions Jaundice neonatal	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.59% 2/341 • Number of events 2 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Pregnancy, puerperium and perinatal conditions Large for dates baby	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/341 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Pregnancy, puerperium and perinatal conditions Placenta praevia haemorrhage	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Pregnancy, puerperium and perinatal conditions Polyhydramnios	0.29% 1/341 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Pregnancy, puerperium and perinatal conditions Postpartum haemorrhage	1.5% 5/341 • Number of events 5 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	2.0% 7/346 • Number of events 7 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Pregnancy, puerperium and perinatal conditions Pre-eclampsia	0.29% 1/341 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	1.4% 5/346 • Number of events 5 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Pregnancy, puerperium and perinatal conditions Premature baby	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	3.2% 11/341 • Number of events 11 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	2.6% 9/346 • Number of events 9 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Pregnancy, puerperium and perinatal conditions Premature delivery	1.2% 4/341 • Number of events 4 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	1.2% 4/346 • Number of events 4 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Pregnancy, puerperium and perinatal conditions Premature labour	3.2% 11/341 • Number of events 12 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	3.2% 11/346 • Number of events 11 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Pregnancy, puerperium and perinatal conditions Premature rupture of membranes	3.8% 13/341 • Number of events 13 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	4.9% 17/346 • Number of events 17 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Pregnancy, puerperium and perinatal conditions Preterm premature rupture of membranes	1.2% 4/341 • Number of events 4 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	1.4% 5/346 • Number of events 5 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Pregnancy, puerperium and perinatal conditions Retained placenta or membranes	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Pregnancy, puerperium and perinatal conditions Small for dates baby	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.88% 3/341 • Number of events 3 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.87% 3/346 • Number of events 3 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Pregnancy, puerperium and perinatal conditions Threatened labour	0.59% 2/341 • Number of events 2 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Pregnancy, puerperium and perinatal conditions Uterine contractions during pregnancy	0.29% 1/341 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Renal and urinary disorders Acute kidney injury	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Renal and urinary disorders Hydronephrosis	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Renal and urinary disorders Vesicoureteric reflux	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Reproductive system and breast disorders Female genital tract fistula	0.29% 1/341 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Reproductive system and breast disorders Metrorrhagia	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Reproductive system and breast disorders Uterine atony	0.29% 1/341 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Reproductive system and breast disorders Uterine haemorrhage	0.59% 2/341 • Number of events 2 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Reproductive system and breast disorders Vaginal haemorrhage	0.59% 2/341 • Number of events 2 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Respiratory, thoracic and mediastinal disorders Apnoea	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/341 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Respiratory, thoracic and mediastinal disorders Asphyxia	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Respiratory, thoracic and mediastinal disorders Meconium aspiration syndrome	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Respiratory, thoracic and mediastinal disorders Neonatal asphyxia	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/341 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Respiratory, thoracic and mediastinal disorders Neonatal respiratory depression	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	1.5% 5/341 • Number of events 5 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	1.2% 4/346 • Number of events 4 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Respiratory, thoracic and mediastinal disorders Transient tachypnoea of the newborn	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Skin and subcutaneous tissue disorders Rash neonatal	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Vascular disorders Deep vein thrombosis	0.29% 1/341 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.

Other adverse events

Other adverse events
Measure	dTpa Group-Mother n=341 participants at risk This group consisted of pregnant women who received a single dose of Boostrix at 27-36 weeks (i.e. completed 27 weeks until 36 weeks) of gestation (Visit 1) and received a dose of the placebo post-delivery (within 72 hours).	Control Group-Mother n=346 participants at risk This group consisted of pregnant women who received a single dose of placebo at 27-36 weeks (i.e. completed 27 weeks until 36 weeks) of gestation (Visit 1) and received a dose of Boostrix post-delivery (within 72 hours).	dTpa Group - Infant n=341 participants at risk This group consisted of infants born to mothers (from dTpa Group Mother) who received a dose of Boostrix during pregnancy.	Control Group-Infant n=346 participants at risk This group consisted of infants born to mothers (from Control Group Mother) who received a dose of placebo during pregnancy	Household Group n=608 participants at risk This group consisted of eligible household contacts of the infants born to pregnant women enrolled in Spain who received a single dose of Boostrix anytime during the study.
Gastrointestinal disorders Abdominal discomfort	0.88% 3/341 • Number of events 3 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Gastrointestinal disorders Abdominal pain	1.2% 4/341 • Number of events 5 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	2.6% 9/341 • Number of events 9 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	1.7% 6/346 • Number of events 6 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Gastrointestinal disorders Abdominal pain lower	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Gastrointestinal disorders Abdominal pain upper	0.29% 1/341 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Psychiatric disorders Affect lability	0.29% 1/341 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Pregnancy, puerperium and perinatal conditions Afterbirth pain	5.0% 17/341 • Number of events 17 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	5.8% 20/346 • Number of events 20 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Skin and subcutaneous tissue disorders Alopecia areata	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Infections and infestations Amniotic cavity infection	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Blood and lymphatic system disorders Anaemia	3.2% 11/341 • Number of events 11 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	4.0% 14/346 • Number of events 14 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Blood and lymphatic system disorders Anaemia of pregnancy	0.88% 3/341 • Number of events 3 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.87% 3/346 • Number of events 3 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Anogenital warts	0.29% 1/341 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Nervous system disorders Aphonia	0.29% 1/341 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Musculoskeletal and connective tissue disorders Arthralgia	0.88% 3/341 • Number of events 3 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
General disorders Asthenia	0.59% 2/341 • Number of events 2 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
General disorders Axillary pain	0.59% 2/341 • Number of events 2 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Musculoskeletal and connective tissue disorders Back pain	3.2% 11/341 • Number of events 11 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	3.8% 13/346 • Number of events 14 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Investigations Blood pressure increased	0.29% 1/341 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Cardiac disorders Bradycardia	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/341 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Reproductive system and breast disorders Breast engorgement	0.59% 2/341 • Number of events 2 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	1.2% 4/346 • Number of events 4 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Reproductive system and breast disorders Breast inflammation	0.59% 2/341 • Number of events 2 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.58% 2/346 • Number of events 2 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Reproductive system and breast disorders Breast mass	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Reproductive system and breast disorders Breast pain	0.29% 1/341 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Infections and infestations Bronchiolitis	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/341 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Infections and infestations Bronchitis	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 2 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Pregnancy, puerperium and perinatal conditions Cephalhaematoma	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/341 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Pregnancy, puerperium and perinatal conditions Cervical dilatation	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Reproductive system and breast disorders Cervical discharge	0.29% 1/341 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.58% 2/346 • Number of events 2 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
General disorders Chills	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Hepatobiliary disorders Cholestasis of pregnancy	0.29% 1/341 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Injury, poisoning and procedural complications Clavicle fracture	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.58% 2/346 • Number of events 2 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Eye disorders Conjunctival haemorrhage	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/341 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Infections and infestations Conjunctivitis	0.29% 1/341 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.87% 3/346 • Number of events 3 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	2.1% 7/341 • Number of events 8 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.87% 3/346 • Number of events 3 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Gastrointestinal disorders Constipation	2.3% 8/341 • Number of events 8 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	2.9% 10/346 • Number of events 10 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/341 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Respiratory, thoracic and mediastinal disorders Cough	1.8% 6/341 • Number of events 6 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	2.0% 7/346 • Number of events 7 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Metabolism and nutrition disorders Cow's milk intolerance	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/341 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Infections and infestations Cystitis	0.29% 1/341 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Eye disorders Dacryostenosis acquired	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.59% 2/341 • Number of events 2 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Ear and labyrinth disorders Deafness	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Psychiatric disorders Depression	0.29% 1/341 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Skin and subcutaneous tissue disorders Dermatitis	0.29% 1/341 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.58% 2/346 • Number of events 2 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	1.2% 4/341 • Number of events 4 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Skin and subcutaneous tissue disorders Dermatitis contact	0.29% 1/341 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Gastrointestinal disorders Diarrhoea	0.88% 3/341 • Number of events 3 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
General disorders Discomfort	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Injury, poisoning and procedural complications Dislocation of vertebra	0.29% 1/341 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Nervous system disorders Dizziness	2.1% 7/341 • Number of events 8 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	1.2% 4/346 • Number of events 4 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Gastrointestinal disorders Dyspepsia	1.2% 4/341 • Number of events 4 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	1.2% 4/346 • Number of events 5 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Renal and urinary disorders Dysuria	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.58% 2/346 • Number of events 2 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Ear and labyrinth disorders Ear pain	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Eye disorders Eczema eyelids	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Infections and infestations Endometritis	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.29% 1/341 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Skin and subcutaneous tissue disorders Erythema	0.59% 2/341 • Number of events 2 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Nervous system disorders Extrapyramidal disorder	0.29% 1/341 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
General disorders Fatigue	55.1% 188/341 • Number of events 276 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	53.8% 186/346 • Number of events 277 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.58% 2/346 • Number of events 2 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Gastrointestinal disorders Flatulence	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Metabolism and nutrition disorders Fluid retention	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Injury, poisoning and procedural complications Foreign body	0.29% 1/341 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Infections and infestations Fungal infection	0.59% 2/341 • Number of events 2 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Infections and infestations Fungal skin infection	0.29% 1/341 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Gastrointestinal disorders Gastritis	0.29% 1/341 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Infections and infestations Gastroenteritis	1.8% 6/341 • Number of events 6 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/341 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Infections and infestations Gastroenteritis viral	0.29% 1/341 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Gastrointestinal disorders Gastrointestinal disorder	22.9% 78/341 • Number of events 92 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	24.0% 83/346 • Number of events 95 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Gastrointestinal disorders Gastrooesophageal reflux disease	2.1% 7/341 • Number of events 7 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	1.7% 6/346 • Number of events 6 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/341 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Infections and infestations Genital herpes	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Infections and infestations Genital infection	0.29% 1/341 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Infections and infestations Genital infection fungal	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 2 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
General disorders Granuloma	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Infections and infestations Groin abscess	0.29% 1/341 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Respiratory, thoracic and mediastinal disorders Grunting	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/341 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Gastrointestinal disorders Haemorrhoids	1.2% 4/341 • Number of events 4 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	2.0% 7/346 • Number of events 7 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Nervous system disorders Headache	37.8% 129/341 • Number of events 169 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	36.4% 126/346 • Number of events 169 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Investigations Heart rate decreased	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Infections and infestations Herpes simplex	0.29% 1/341 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Infections and infestations Hordeolum	0.29% 1/341 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Vascular disorders Hot flush	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.59% 2/341 • Number of events 2 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.58% 2/346 • Number of events 2 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Vascular disorders Hypertension	0.29% 1/341 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Vascular disorders Hypotension	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
General disorders Hypothermia	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/341 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Endocrine disorders Hypothyroidism	0.29% 1/341 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
General disorders Impaired healing	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Injury, poisoning and procedural complications Incision site pain	0.29% 1/341 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Infections and infestations Influenza	0.59% 2/341 • Number of events 2 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.58% 2/346 • Number of events 2 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
General disorders Influenza like illness	0.88% 3/341 • Number of events 3 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Skin and subcutaneous tissue disorders Ingrowing nail	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.58% 2/346 • Number of events 2 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Gastrointestinal disorders Inguinal hernia	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
General disorders Injection site bruising	0.59% 2/341 • Number of events 2 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
General disorders Injection site erythema	31.1% 106/341 • Number of events 130 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	33.8% 117/346 • Number of events 142 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
General disorders Injection site haematoma	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.87% 3/346 • Number of events 3 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
General disorders Injection site induration	0.29% 1/341 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
General disorders Injection site mass	0.29% 1/341 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
General disorders Injection site pain	85.0% 290/341 • Number of events 330 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	64.5% 223/346 • Number of events 258 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
General disorders Injection site pruritus	1.2% 4/341 • Number of events 4 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
General disorders Injection site rash	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
General disorders Injection site reaction	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
General disorders Injection site swelling	26.7% 91/341 • Number of events 101 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	26.6% 92/346 • Number of events 99 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
General disorders Injection site urticaria	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Psychiatric disorders Insomnia	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.87% 3/346 • Number of events 3 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Metabolism and nutrition disorders Iron deficiency	0.29% 1/341 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Psychiatric disorders Irritability	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Hepatobiliary disorders Jaundice	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.59% 2/341 • Number of events 2 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	1.4% 5/346 • Number of events 5 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Injury, poisoning and procedural complications Joint injury	0.29% 1/341 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Pregnancy, puerperium and perinatal conditions Labour pain	0.59% 2/341 • Number of events 2 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.87% 3/346 • Number of events 3 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Injury, poisoning and procedural complications Laceration	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Musculoskeletal and connective tissue disorders Ligament pain	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.58% 2/346 • Number of events 2 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Injury, poisoning and procedural complications Ligament sprain	0.29% 1/341 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Musculoskeletal and connective tissue disorders Limb discomfort	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
General disorders Malaise	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/341 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Infections and infestations Mastitis	2.9% 10/341 • Number of events 10 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	4.0% 14/346 • Number of events 14 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Infections and infestations Mastitis postpartum	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Melanocytic naevus	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Reproductive system and breast disorders Menorrhagia	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Reproductive system and breast disorders Metrorrhagia	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.58% 2/346 • Number of events 2 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Nervous system disorders Migraine	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Nervous system disorders Migraine with aura	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Immune system disorders Milk allergy	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/341 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Musculoskeletal and connective tissue disorders Muscle haemorrhage	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/341 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.29% 1/341 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Musculoskeletal and connective tissue disorders Myalgia	0.88% 3/341 • Number of events 3 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.87% 3/346 • Number of events 3 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.88% 3/341 • Number of events 3 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	1.2% 4/346 • Number of events 4 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Respiratory, thoracic and mediastinal disorders Nasal obstruction	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Infections and infestations Nasopharyngitis	2.1% 7/341 • Number of events 7 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	3.5% 12/346 • Number of events 12 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Musculoskeletal and connective tissue disorders Neck pain	0.29% 1/341 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.87% 3/346 • Number of events 3 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Reproductive system and breast disorders Nipple disorder	0.29% 1/341 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Infections and infestations Nipple infection	0.29% 1/341 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Reproductive system and breast disorders Nipple inflammation	0.29% 1/341 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Reproductive system and breast disorders Nipple pain	0.29% 1/341 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
General disorders Nodule	0.29% 1/341 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Pregnancy, puerperium and perinatal conditions Oligohydramnios	0.29% 1/341 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Infections and infestations Oral candidiasis	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/341 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Infections and infestations Oral herpes	0.29% 1/341 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 2 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	3.8% 13/341 • Number of events 13 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	3.8% 13/346 • Number of events 13 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Infections and infestations Otitis media acute	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.58% 2/346 • Number of events 2 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Reproductive system and breast disorders Ovarian cyst torsion	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/341 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Musculoskeletal and connective tissue disorders Pain in extremity	0.59% 2/341 • Number of events 2 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.87% 3/346 • Number of events 3 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Nervous system disorders Paraesthesia	0.29% 1/341 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Nervous system disorders Paralysis	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Reproductive system and breast disorders Pelvic pain	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Reproductive system and breast disorders Perineal pain	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.87% 3/346 • Number of events 3 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Infections and infestations Periodontitis	0.29% 1/341 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
General disorders Peripheral swelling	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Infections and infestations Pharyngitis	0.59% 2/341 • Number of events 2 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.87% 3/346 • Number of events 3 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Vascular disorders Phlebitis	0.29% 1/341 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.58% 2/346 • Number of events 2 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Infections and infestations Pneumonia	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Injury, poisoning and procedural complications Post procedural haematoma	0.59% 2/341 • Number of events 2 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Injury, poisoning and procedural complications Post procedural inflammation	0.29% 1/341 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Infections and infestations Postoperative abscess	0.29% 1/341 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Infections and infestations Postoperative wound infection	0.59% 2/341 • Number of events 2 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.87% 3/346 • Number of events 3 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Injury, poisoning and procedural complications Procedural haemorrhage	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Injury, poisoning and procedural complications Procedural headache	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Injury, poisoning and procedural complications Procedural pain	0.88% 3/341 • Number of events 3 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.58% 2/346 • Number of events 2 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Skin and subcutaneous tissue disorders Pruritus generalised	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Reproductive system and breast disorders Pruritus genital	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Renal and urinary disorders Pyelocaliectasis	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/341 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Infections and infestations Pyelonephritis	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
General disorders Pyrexia	5.9% 20/341 • Number of events 20 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	9.2% 32/346 • Number of events 33 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Skin and subcutaneous tissue disorders Rash	0.29% 1/341 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Vascular disorders Raynaud's phenomenon	0.29% 1/341 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Renal and urinary disorders Renal colic	0.29% 1/341 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Infections and infestations Respiratory tract infection	0.59% 2/341 • Number of events 2 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Infections and infestations Respiratory tract infection viral	0.59% 2/341 • Number of events 2 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.58% 2/346 • Number of events 2 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Nervous system disorders Restless legs syndrome	0.29% 1/341 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Infections and infestations Rhinitis	0.29% 1/341 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.87% 3/346 • Number of events 3 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.59% 2/341 • Number of events 2 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Nervous system disorders Sciatica	0.29% 1/341 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.58% 2/346 • Number of events 3 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Immune system disorders Seasonal allergy	0.29% 1/341 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Respiratory, thoracic and mediastinal disorders Sinus congestion	0.29% 1/341 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Infections and infestations Sinusitis	0.59% 2/341 • Number of events 2 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.87% 3/346 • Number of events 3 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Pregnancy, puerperium and perinatal conditions Small for dates baby	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/341 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Nervous system disorders Somnolence	0.29% 1/341 • Number of events 2 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Gastrointestinal disorders Stomatitis	0.29% 1/341 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Reproductive system and breast disorders Suppressed lactation	0.59% 2/341 • Number of events 2 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Cardiac disorders Supraventricular extrasystoles	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Injury, poisoning and procedural complications Suture related complication	0.29% 1/341 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Injury, poisoning and procedural complications Suture rupture	0.29% 1/341 • Number of events 2 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
General disorders Swelling	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Nervous system disorders Syncope	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Respiratory, thoracic and mediastinal disorders Throat irritation	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Vascular disorders Thrombosis	0.29% 1/341 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Endocrine disorders Thyroid dysfunction in pregnancy	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Infections and infestations Tinea pedis	0.29% 1/341 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Gastrointestinal disorders Toothache	0.59% 2/341 • Number of events 2 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Respiratory, thoracic and mediastinal disorders Transient tachypnoea of the newborn	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.58% 2/346 • Number of events 2 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Pregnancy, puerperium and perinatal conditions Traumatic delivery	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Gastrointestinal disorders Umbilical hernia	0.29% 1/341 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Infections and infestations Upper respiratory tract infection	3.2% 11/341 • Number of events 12 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	3.8% 13/346 • Number of events 13 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.88% 3/341 • Number of events 3 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Respiratory, thoracic and mediastinal disorders Upper-airway cough syndrome	0.29% 1/341 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Renal and urinary disorders Urethral prolapse	0.29% 1/341 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Infections and infestations Urinary tract infection	2.3% 8/341 • Number of events 8 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	2.9% 10/346 • Number of events 11 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Skin and subcutaneous tissue disorders Urticaria	0.59% 2/341 • Number of events 2 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Pregnancy, puerperium and perinatal conditions Uterine contractions during pregnancy	0.88% 3/341 • Number of events 3 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Pregnancy, puerperium and perinatal conditions Uterine hypotonus	0.88% 3/341 • Number of events 3 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.58% 2/346 • Number of events 2 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Pregnancy, puerperium and perinatal conditions Uterine irritability	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Reproductive system and breast disorders Uterine pain	0.29% 1/341 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Reproductive system and breast disorders Uterine prolapse	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
General disorders Vaccination site pain	0.29% 1/341 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Reproductive system and breast disorders Vaginal discharge	0.29% 1/341 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Infections and infestations Vaginal infection	0.29% 1/341 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.58% 2/346 • Number of events 2 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Vascular disorders Varicose vein	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Reproductive system and breast disorders Varicose veins vulval	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.58% 2/346 • Number of events 2 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
General disorders Vessel puncture site bruise	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Gastrointestinal disorders Vomiting	0.59% 2/341 • Number of events 2 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Infections and infestations Vulvovaginal candidiasis	0.29% 1/341 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Infections and infestations Vulvovaginal mycotic infection	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Reproductive system and breast disorders Vulvovaginal pain	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.29% 1/346 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.
Injury, poisoning and procedural complications Wound dehiscence	0.29% 1/341 • Number of events 1 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.87% 3/346 • Number of events 3 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/341 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/346 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.	0.00% 0/608 • For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination. No solicited symptoms were assessed for the Infants' Groups and Household Group.

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