Trial Outcomes & Findings for Immune Response Induced by a Vaccine Against Group B Streptococcus and Safety in Pregnant Women and Their Offsprings (NCT NCT01446289)

NCT ID: NCT01446289

Last Updated: 2014-09-08

Results Overview

GMCs of anti-Group B Streptococcus (GBS) capsular polysaccharide (CPS) antibodies against serotypes Ia, Ib and III in mothers and in infants at delivery/birth are presented.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 86 participants
• Primary outcome timeframe: Day of delivery/birth
• Results posted on: 2014-09-08

Participant Flow

Participants were recruited from 5 centres.

A total of 86 pregnant subjects were enrolled in the study. 86 infants were enrolled in this study, delivered by 86 maternal subjects. There were 86 singleton deliveries.

Participant milestones

Measure	Mothers GBS Pregnant women who received one injection of GBS vaccine.	Mothers Placebo Pregnant women who received one injection of saline solution.	Infants GBS Infants born from mothers who received one injection of GBS vaccine.	Infants Placebo Infants born from mothers who received one injection of saline solution.
Overall Study STARTED	51	35	51	35
Overall Study COMPLETED	50	35	50	35
Overall Study NOT COMPLETED	1	0	1	0

Reasons for withdrawal

Measure	Mothers GBS Pregnant women who received one injection of GBS vaccine.	Mothers Placebo Pregnant women who received one injection of saline solution.	Infants GBS Infants born from mothers who received one injection of GBS vaccine.	Infants Placebo Infants born from mothers who received one injection of saline solution.
Overall Study Withdrawal by Subject	1	0	1	0

Baseline Characteristics

Immune Response Induced by a Vaccine Against Group B Streptococcus and Safety in Pregnant Women and Their Offsprings

Baseline characteristics by cohort

Measure	Mothers GBS n=51 Participants Pregnant women who received one injection of GBS vaccine.	Mothers Placebo n=35 Participants Pregnant women who received one injection of saline solution.	Infants GBS n=51 Participants Infants born from mothers who received one injection of GBS vaccine.	Infants Placebo n=35 Participants Infants born from mothers who received one injection of saline solution.	Total n=172 Participants Total of all reporting groups
Age, Continuous	NA days STANDARD_DEVIATION NA • n=5 Participants	NA days STANDARD_DEVIATION NA • n=7 Participants	0 days STANDARD_DEVIATION 0 • n=5 Participants	0 days STANDARD_DEVIATION 0 • n=4 Participants	0 days STANDARD_DEVIATION 0 • n=21 Participants
Sex: Female, Male Female	51 Participants n=5 Participants	35 Participants n=7 Participants	21 Participants n=5 Participants	15 Participants n=4 Participants	122 Participants n=21 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	30 Participants n=5 Participants	20 Participants n=4 Participants	50 Participants n=21 Participants
Region of Enrollment Canada	15 participants n=5 Participants	11 participants n=7 Participants	15 participants n=5 Participants	11 participants n=4 Participants	52 participants n=21 Participants
Region of Enrollment Belgium	36 participants n=5 Participants	24 participants n=7 Participants	36 participants n=5 Participants	24 participants n=4 Participants	120 participants n=21 Participants

PRIMARY outcome

Timeframe: Day of delivery/birth

Population: The analysis was done on the Immunogenicity Per Protocol Set (PPS), ie: all subjects in the enrolled population who correctly received the vaccine, provided evaluable serum samples at the relevant time points and had no major protocol violation as defined prior to un-blinding.

GMCs of anti-Group B Streptococcus (GBS) capsular polysaccharide (CPS) antibodies against serotypes Ia, Ib and III in mothers and in infants at delivery/birth are presented.

Outcome measures

Measure	Mothers GBS n=45 Participants Pregnant women who received one injection of GBS vaccine.	Mothers Placebo n=30 Participants Pregnant women who received one injection of saline solution.	Infants GBS n=45 Participants Infants born from mothers who received one injection of GBS vaccine.	Infants Placebo n=30 Participants Infants born from mothers who received one injection of saline solution.
Geometric Mean Concentrations (GMCs) of Antibodies in Mothers and Infants at Delivery/Birth GBS Ia	5.39 µg/mL Interval 2.97 to 9.77	0.41 µg/mL Interval 0.2 to 0.85	4.37 µg/mL Interval 2.39 to 7.99	0.4 µg/mL Interval 0.19 to 0.83
Geometric Mean Concentrations (GMCs) of Antibodies in Mothers and Infants at Delivery/Birth GBS Ib (N=40, 22, 40, 22)	3.35 µg/mL Interval 1.44 to 7.77	0.064 µg/mL Interval 0.021 to 0.19	2.59 µg/mL Interval 1.14 to 5.87	0.092 µg/mL Interval 0.032 to 0.27
Geometric Mean Concentrations (GMCs) of Antibodies in Mothers and Infants at Delivery/Birth GBS III (N=40, 25, 40, 25)	2.45 µg/mL Interval 1.15 to 5.2	0.056 µg/mL Interval 0.022 to 0.14	1.65 µg/mL Interval 0.78 to 3.5	0.055 µg/mL Interval 0.022 to 0.14

PRIMARY outcome

Timeframe: Day of delivery/birth

Population: The analysis was done on the Immunogenicity PPS.

The Geometric mean transfer ratio of anti-GBS CPS antibodies against serotypes Ia, Ib and III at delivery is calculated as the geometric mean of the pairwise ratios between the antibody concentrations from infant at birth and to maternal serum concentration at delivery.

Outcome measures

Measure	Mothers GBS n=45 Participants Pregnant women who received one injection of GBS vaccine.	Mothers Placebo n=30 Participants Pregnant women who received one injection of saline solution.	Infants GBS Infants born from mothers who received one injection of GBS vaccine.	Infants Placebo Infants born from mothers who received one injection of saline solution.
Geometric Mean of the Ratios Between Infant Antibody Level (μg/mL) and Maternal Antibody Level (μg/mL) at Time of Delivery GBS Ia	0.81 Ratio Interval 0.72 to 0.91	0.97 Ratio Interval 0.85 to 1.11	—	—
Geometric Mean of the Ratios Between Infant Antibody Level (μg/mL) and Maternal Antibody Level (μg/mL) at Time of Delivery GBS Ib (N=40, 22)	0.77 Ratio Interval 0.62 to 0.97	1.44 Ratio Interval 1.06 to 1.94	—	—
Geometric Mean of the Ratios Between Infant Antibody Level (μg/mL) and Maternal Antibody Level (μg/mL) at Time of Delivery GBS III (N=40, 25)	0.68 Ratio Interval 0.59 to 0.78	0.99 Ratio Interval 0.83 to 1.18	—	—

SECONDARY outcome

Timeframe: Day 1, day 31 and day 91 post-delivery

Population: The analysis was done on the Immunogenicity PPS.

GMCs (ELISA) of anti-GBS CPS antibodies against serotypes Ia, Ib and III in maternal subjects at study day 1, study day 31 and at day 91 post-partum after one administration of GBS vaccine or placebo are reported.

Outcome measures

Measure	Mothers GBS n=51 Participants Pregnant women who received one injection of GBS vaccine.	Mothers Placebo n=35 Participants Pregnant women who received one injection of saline solution.	Infants GBS Infants born from mothers who received one injection of GBS vaccine.	Infants Placebo Infants born from mothers who received one injection of saline solution.
GMCs (Enzyme-linked Immunosorbent Assay, ELISA) Antibodies Against Serotypes Ia, Ib and III in Maternal Subjects GBS III (day 1)	0.11 µg/mL Interval 0.07 to 0.16	0.093 µg/mL Interval 0.056 to 0.15	—	—
GMCs (Enzyme-linked Immunosorbent Assay, ELISA) Antibodies Against Serotypes Ia, Ib and III in Maternal Subjects GBS Ia (day 1)	0.28 µg/mL Interval 0.19 to 0.41	0.37 µg/mL Interval 0.24 to 0.58	—	—
GMCs (Enzyme-linked Immunosorbent Assay, ELISA) Antibodies Against Serotypes Ia, Ib and III in Maternal Subjects GBS Ia (day 31; N=49, 32)	4.83 µg/mL Interval 2.89 to 8.06	0.36 µg/mL Interval 0.19 to 0.65	—	—
GMCs (Enzyme-linked Immunosorbent Assay, ELISA) Antibodies Against Serotypes Ia, Ib and III in Maternal Subjects GBS Ia (day 91 post-delivery; N = 44, 34)	5.89 µg/mL Interval 3.86 to 8.99	0.46 µg/mL Interval 0.29 to 0.75	—	—
GMCs (Enzyme-linked Immunosorbent Assay, ELISA) Antibodies Against Serotypes Ia, Ib and III in Maternal Subjects GBS Ib (day 1; N= 50, 34)	0.13 µg/mL Interval 0.084 to 0.19	0.084 µg/mL Interval 0.051 to 0.14	—	—
GMCs (Enzyme-linked Immunosorbent Assay, ELISA) Antibodies Against Serotypes Ia, Ib and III in Maternal Subjects GBS Ib (day 31; N=49, 31)	1.68 µg/mL Interval 0.97 to 2.92	0.14 µg/mL Interval 0.069 to 0.27	—	—
GMCs (Enzyme-linked Immunosorbent Assay, ELISA) Antibodies Against Serotypes Ia, Ib and III in Maternal Subjects GBS Ib (day 91 post-delivery; N= 44, 33)	3.46 µg/mL Interval 2.33 to 5.14	0.17 µg/mL Interval 0.11 to 0.27	—	—
GMCs (Enzyme-linked Immunosorbent Assay, ELISA) Antibodies Against Serotypes Ia, Ib and III in Maternal Subjects GBS III (day 31; N= 49, 32)	1.46 µg/mL Interval 0.83 to 2.57	0.12 µg/mL Interval 0.06 to 0.23	—	—
GMCs (Enzyme-linked Immunosorbent Assay, ELISA) Antibodies Against Serotypes Ia, Ib and III in Maternal Subjects GBS III (day 91 post-delivery; N=44, 34)	2.69 µg/mL Interval 1.78 to 4.06	0.11 µg/mL Interval 0.07 to 0.18	—	—

SECONDARY outcome

Timeframe: Day 31, day of delivery, day 91 post-delivery

Population: The analysis was done on the Immunogenicity PPS.

GMRs of GMCs (ELISA) of anti-GBS CPS antibodies against serotypes Ia, Ib and III, in maternal subjects at study day 31, at delivery and at day 91 post-partum versus day 1 (baseline) after one administration of GBS vaccine or placebo are reported.

Outcome measures

Measure	Mothers GBS n=110 strains Pregnant women who received one injection of GBS vaccine.	Mothers Placebo n=110 strains Pregnant women who received one injection of saline solution.	Infants GBS Infants born from mothers who received one injection of GBS vaccine.	Infants Placebo Infants born from mothers who received one injection of saline solution.
Geometric Mean Ratios (GMRs) of Antibody GMCs (ELISA) in Maternal Subjects GBS Ia (Day 31/day 1; N=49, 32)	15 Ratio Interval 9.12 to 25.0	1.22 Ratio Interval 0.66 to 2.25	—	—
Geometric Mean Ratios (GMRs) of Antibody GMCs (ELISA) in Maternal Subjects GBS Ia (Delivery/day 1)	16 Ratio Interval 11.0 to 25.0	1.2 Ratio Interval 0.72 to 2.01	—	—
Geometric Mean Ratios (GMRs) of Antibody GMCs (ELISA) in Maternal Subjects GBS Ia (day 91 post-delivery/day 1; N= 44, 34)	19 Ratio Interval 12.0 to 28.0	1.51 Ratio Interval 0.94 to 2.42	—	—
Geometric Mean Ratios (GMRs) of Antibody GMCs (ELISA) in Maternal Subjects GBS Ib (Day 31/day 1; N=48, 30)	18 Ratio Interval 9.94 to 32.0	1.14 Ratio Interval 0.56 to 2.35	—	—
Geometric Mean Ratios (GMRs) of Antibody GMCs (ELISA) in Maternal Subjects GBS Ib (Delivery/day 1; N=50, 34)	23 Ratio Interval 14.0 to 39.0	1.13 Ratio Interval 0.63 to 2.05	—	—
Geometric Mean Ratios (GMRs) of Antibody GMCs (ELISA) in Maternal Subjects GBS Ib (day 91 post-delivery/day 1; N=44, 32)	33 Ratio Interval 22.0 to 48.0	1.53 Ratio Interval 0.96 to 2.43	—	—
Geometric Mean Ratios (GMRs) of Antibody GMCs (ELISA) in Maternal Subjects GBS III (Day 31/day 1; N=49, 32)	17 Ratio Interval 9.17 to 30.0	1.19 Ratio Interval 0.59 to 2.42	—	—
Geometric Mean Ratios (GMRs) of Antibody GMCs (ELISA) in Maternal Subjects GBS III (Delivery/day 1)	20 Ratio Interval 12.0 to 33.0	1.08 Ratio Interval 0.6 to 1.96	—	—
Geometric Mean Ratios (GMRs) of Antibody GMCs (ELISA) in Maternal Subjects GBS III (day 91 post-delivery/day 1; N=44, 34)	28 Ratio Interval 18.0 to 43.0	1.11 Ratio Interval 0.69 to 1.8	—	—

SECONDARY outcome

Timeframe: Day of birth and day 91 after birth

Population: The analysis was done on the Immunogenicity PPS.

GMC (ELISA) of anti-GBS CPS antibodies against serotypes Ia, Ib and III in infants at birth and at 3 months of age are reported.

Outcome measures

Measure	Mothers GBS n=35 Participants Pregnant women who received one injection of GBS vaccine.	Mothers Placebo n=25 Participants Pregnant women who received one injection of saline solution.	Infants GBS Infants born from mothers who received one injection of GBS vaccine.	Infants Placebo Infants born from mothers who received one injection of saline solution.
GMC (ELISA) of Anti-GBS CPS Antibodies in Infants GBS Ia (day of birth)	5.14 μg/mL Interval 2.64 to 10.0	0.33 μg/mL Interval 0.15 to 0.71	—	—
GMC (ELISA) of Anti-GBS CPS Antibodies in Infants GBS Ia (day 91 after birth)	1.28 μg/mL Interval 0.76 to 2.16	0.25 μg/mL Interval 0.13 to 0.46	—	—
GMC (ELISA) of Anti-GBS CPS Antibodies in Infants GBS Ib (day of birth; N=31, 20)	2.93 μg/mL Interval 1.14 to 7.57	0.1 μg/mL Interval 0.031 to 0.32	—	—
GMC (ELISA) of Anti-GBS CPS Antibodies in Infants GBS Ib (day 91 after birth)	0.54 μg/mL Interval 0.25 to 1.19	0.063 μg/mL Interval 0.025 to 0.16	—	—
GMC (ELISA) of Anti-GBS CPS Antibodies in Infants GBS III (day of birth; N=30, 22)	1.93 μg/mL Interval 0.82 to 4.59	0.065 μg/mL Interval 0.024 to 0.18	—	—
GMC (ELISA) of Anti-GBS CPS Antibodies in Infants GBS III (day 91 after birth)	0.43 μg/mL Interval 0.21 to 0.86	0.065 μg/mL Interval 0.029 to 0.15	—	—

SECONDARY outcome

Timeframe: Day 91 after birth

Population: The analysis was done on the Immunogenicity PPS.

GMRs of anti-GBS CPS antibody GMCs (ELISA) against serotypes Ia, Ib and III in infants at 3 months of age (day 91 after birth) versus GMCs at birth are reported.

Outcome measures

Measure	Mothers GBS n=35 Participants Pregnant women who received one injection of GBS vaccine.	Mothers Placebo n=25 Participants Pregnant women who received one injection of saline solution.	Infants GBS Infants born from mothers who received one injection of GBS vaccine.	Infants Placebo Infants born from mothers who received one injection of saline solution.
GMRs of Anti-GBS CPS Antibody GMCs (ELISA) in Infants at 3 Months of Age Versus GMCs at Birth GBS Ia	0.25 Ratio Interval 0.19 to 0.32	0.76 Ratio Interval 0.57 to 1.01	—	—
GMRs of Anti-GBS CPS Antibody GMCs (ELISA) in Infants at 3 Months of Age Versus GMCs at Birth GBS Ib (N=31, 20 )	0.22 Ratio Interval 0.16 to 0.29	0.54 Ratio Interval 0.38 to 0.78	—	—
GMRs of Anti-GBS CPS Antibody GMCs (ELISA) in Infants at 3 Months of Age Versus GMCs at Birth GBS III (N=30, 22)	0.25 Ratio Interval 0.19 to 0.32	0.85 Ratio Interval 0.62 to 1.16	—	—

SECONDARY outcome

Timeframe: 1 month after the last routine infant immunization

Population: The analysis was done on the Immunogenicity PPS.

Percentages of infant subjects showing anti-diphtheria antibodies GMCs (ELISA) over 0.1 IU/mL in sera collected at 1 month after the last routine infant immunization (ie, either 5 months or 7 months after birth, depending on the vaccination schedule) are reported.

Outcome measures

Measure	Mothers GBS n=40 Participants Pregnant women who received one injection of GBS vaccine.	Mothers Placebo n=27 Participants Pregnant women who received one injection of saline solution.	Infants GBS Infants born from mothers who received one injection of GBS vaccine.	Infants Placebo Infants born from mothers who received one injection of saline solution.
Percentages of Infant Subjects Showing Anti-diphtheria Antibodies GMCs (ELISA) Over 0.1 IU/mL at 1 Month After the Last Routine Infant Immunization	100 Percentages of subjects Interval 91.0 to 100.0	100 Percentages of subjects Interval 87.0 to 100.0	—	—

SECONDARY outcome

Timeframe: From day 1 to 7 after vaccination

Population: The analysis was done on the Safety Set, ie, all subjects in the enrolled population who received a study vaccination, provided post vaccination safety data, provided post-baseline safety data.

Percentage of maternal subjects reporting solicited local and systemic AEs and other indicators of reactogenicity from day 1 to 7 after vaccination are reported.

Outcome measures

Measure	Mothers GBS n=50 Participants Pregnant women who received one injection of GBS vaccine.	Mothers Placebo n=34 Participants Pregnant women who received one injection of saline solution.	Infants GBS Infants born from mothers who received one injection of GBS vaccine.	Infants Placebo Infants born from mothers who received one injection of saline solution.
Percentage of Maternal Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) Any local	40 Percentages of subjects	24 Percentages of subjects	—	—
Percentage of Maternal Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) Induration (>=25 mm; N =49, 34)	6 Percentages of subjects	0 Percentages of subjects	—	—
Percentage of Maternal Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) Swelling (>=25 mm; N =49, 34)	4 Percentages of subjects	0 Percentages of subjects	—	—
Percentage of Maternal Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) Ecchymosis (>=25 mm; N =49, 34 )	2 Percentages of subjects	0 Percentages of subjects	—	—
Percentage of Maternal Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) Erythema (>=25 mm; N =49, 34)	6 Percentages of subjects	0 Percentages of subjects	—	—
Percentage of Maternal Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) Pain (N =49, 34)	35 Percentages of subjects	12 Percentages of subjects	—	—
Percentage of Maternal Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) Any systemic	46 Percentages of subjects	38 Percentages of subjects	—	—
Percentage of Maternal Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) Chills (N =49, 34)	4 Percentages of subjects	3 Percentages of subjects	—	—
Percentage of Maternal Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) Fatigue (N =49, 34)	31 Percentages of subjects	26 Percentages of subjects	—	—
Percentage of Maternal Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) Malaise (N =49, 34)	14 Percentages of subjects	9 Percentages of subjects	—	—
Percentage of Maternal Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) Myalgia (N =49, 34)	27 Percentages of subjects	3 Percentages of subjects	—	—
Percentage of Maternal Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) Headache (N =49, 34)	16 Percentages of subjects	21 Percentages of subjects	—	—
Percentage of Maternal Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) Rash (N =49, 34)	2 Percentages of subjects	3 Percentages of subjects	—	—
Percentage of Maternal Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) Arthralgia (N =49, 34)	4 Percentages of subjects	9 Percentages of subjects	—	—
Percentage of Maternal Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) Nausea (N =49, 34)	6 Percentages of subjects	9 Percentages of subjects	—	—
Percentage of Maternal Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) Fever, body temperature >38° C (N =49, 33)	0 Percentages of subjects	0 Percentages of subjects	—	—
Percentage of Maternal Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) Any other	8 Percentages of subjects	3 Percentages of subjects	—	—
Percentage of Maternal Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) Stayed home (N =49, 34)	2 Percentages of subjects	0 Percentages of subjects	—	—
Percentage of Maternal Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) Use of analgesics/antipyretics (N =49, 34)	6 Percentages of subjects	3 Percentages of subjects	—	—

SECONDARY outcome

Timeframe: All AEs were recorded until delivery, after delivery all AEs requiring a non-routine physician's visit and AEs leading to withdrawal from the study. SAEs were collected for the duration of the trial.

Population: The analysis was done on the Safety Set.

Percentage of maternal subjects reporting unsolicited AEs, SAEs, AEs requiring a non-routine physician's visit, AEs leading to withdrawal are reported.

Outcome measures

Measure	Mothers GBS n=51 Participants Pregnant women who received one injection of GBS vaccine.	Mothers Placebo n=35 Participants Pregnant women who received one injection of saline solution.	Infants GBS Infants born from mothers who received one injection of GBS vaccine.	Infants Placebo Infants born from mothers who received one injection of saline solution.
Percentage of Maternal Subjects Reporting Unsolicited AEs and Serious Adverse Events (SAEs) Any unsolicited AE	63 Percentages of subjects	74 Percentages of subjects	—	—
Percentage of Maternal Subjects Reporting Unsolicited AEs and Serious Adverse Events (SAEs) Any SAE	14 Percentages of subjects	23 Percentages of subjects	—	—
Percentage of Maternal Subjects Reporting Unsolicited AEs and Serious Adverse Events (SAEs) Medically-attended AEs	51 Percentages of subjects	54 Percentages of subjects	—	—
Percentage of Maternal Subjects Reporting Unsolicited AEs and Serious Adverse Events (SAEs) AEs leading to withdrawal	0 Percentages of subjects	0 Percentages of subjects	—	—

SECONDARY outcome

Timeframe: From birth until study termination

Population: The analysis was done on the Safety Set.

Percentages of infants born from women who received either one injection of the study vaccine or placebo, reporting SAEs from birth until study termination are reported.

Outcome measures

Measure	Mothers GBS n=51 Participants Pregnant women who received one injection of GBS vaccine.	Mothers Placebo n=35 Participants Pregnant women who received one injection of saline solution.	Infants GBS Infants born from mothers who received one injection of GBS vaccine.	Infants Placebo Infants born from mothers who received one injection of saline solution.
Percentages of Infants Reporting SAEs	24 Percentages of subjects	31 Percentages of subjects	—	—

Adverse Events

Mothers GBS

Serious events: 7 serious events

Other events: 35 other events

Deaths: 0 deaths

Mothers Placebo

Serious events: 8 serious events

Other events: 24 other events

Deaths: 0 deaths

Infants GBS

Serious events: 12 serious events

Other events: 0 other events

Deaths: 0 deaths

Infants Placebo

Serious events: 11 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Measure	Mothers GBS n=51 participants at risk Pregnant women who received one dose of GBS vaccine.	Mothers Placebo n=35 participants at risk Pregnant women who received one injection of saline solution.	Infants GBS n=51 participants at risk Infants born from mothers who received one dose of GBS vaccine.	Infants Placebo n=35 participants at risk Infants born from mothers who received one injection of saline solution.
Congenital, familial and genetic disorders Renal hypoplasia	2.0% 1/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.
Blood and lymphatic system disorders Jaundice acholuric	0.00% 0/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	2.9% 1/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.
Congenital, familial and genetic disorders Cataract congenital	0.00% 0/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	2.9% 1/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.
Congenital, familial and genetic disorders Renal dysplasia	0.00% 0/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	2.0% 1/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.
Congenital, familial and genetic disorders Trisomy 21	0.00% 0/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	2.0% 1/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.
Congenital, familial and genetic disorders Ventricular septal defect	0.00% 0/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	2.9% 1/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.
General disorders Crying	0.00% 0/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	2.9% 1/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.
General disorders Pyrexia	2.0% 1/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	2.0% 1/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.
Hepatobiliary disorders Jaundice	0.00% 0/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	2.0% 1/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.
Infections and infestations Appendicitis	0.00% 0/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	2.9% 1/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.
Infections and infestations Gastroenteritis	2.0% 1/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.
Infections and infestations Respiratory syncytial virus bronchiolitis	0.00% 0/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	2.0% 1/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.
Infections and infestations Respiratory syncytial virus infection	0.00% 0/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	2.0% 1/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	2.9% 1/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.
Infections and infestations Sepsis neonatal	0.00% 0/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	2.0% 1/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.
Infections and infestations Urinary tract infection	0.00% 0/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	2.9% 1/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.
Infections and infestations Viral infection	0.00% 0/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	2.0% 1/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	2.9% 1/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.
Injury, poisoning and procedural complications Post procedural haemorrage	0.00% 0/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	2.9% 1/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.
Injury, poisoning and procedural complications Brachial plexus injury	0.00% 0/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	2.9% 1/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.
Investigations Foetal monitoring	0.00% 0/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	2.9% 1/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	2.9% 1/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.
Metabolism and nutrition disorders Failure to thrive	0.00% 0/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	2.0% 1/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.
Metabolism and nutrition disorders Feeding disorder	0.00% 0/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	2.0% 1/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Haemangioma	0.00% 0/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	2.9% 1/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.
Musculoskeletal and connective tissue disorders Foot deformity	0.00% 0/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	2.0% 1/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.
Nervous system disorders Myoclonus	0.00% 0/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	2.9% 1/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.
Nervous system disorders Presyncope	0.00% 0/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	2.0% 1/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.
Pregnancy, puerperium and perinatal conditions Arrested labour	2.0% 1/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.
Pregnancy, puerperium and perinatal conditions Cephalo-pelvic disproportion	0.00% 0/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	2.9% 1/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.
Pregnancy, puerperium and perinatal conditions Foetal distress syndrome	2.0% 1/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.
Pregnancy, puerperium and perinatal conditions Foetal growth restriction	0.00% 0/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	2.9% 1/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.
Pregnancy, puerperium and perinatal conditions Low birth weight baby	0.00% 0/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	2.0% 1/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.
Pregnancy, puerperium and perinatal conditions Placental insufficiency	0.00% 0/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	2.9% 1/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.
Pregnancy, puerperium and perinatal conditions Pre-eclampsia	0.00% 0/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	2.9% 1/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.
Pregnancy, puerperium and perinatal conditions Premature delivery	0.00% 0/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	2.9% 1/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.
Pregnancy, puerperium and perinatal conditions Premature labour	0.00% 0/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	5.7% 2/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.
Pregnancy, puerperium and perinatal conditions Premature separation of placenta	0.00% 0/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	2.9% 1/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.
Pregnancy, puerperium and perinatal conditions Small for dates baby	0.00% 0/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	2.9% 1/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.
Pregnancy, puerperium and perinatal conditions Umbilical cord prolapse	0.00% 0/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	2.9% 1/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.
Pregnancy, puerperium and perinatal conditions Unstable foetal lie	0.00% 0/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	2.9% 1/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.
Psychiatric disorders Acute psychosis	2.0% 1/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.
Psychiatric disorders Postpartum depression	2.0% 1/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.
Renal and urinary disorders Renal hypertrophy	0.00% 0/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	2.0% 1/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.
Reproductive system and breast disorders Cervix disorder	2.0% 1/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.
Reproductive system and breast disorders Ovarian cyst	0.00% 0/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	2.0% 1/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.
Reproductive system and breast disorders Vaginal haemorrage	0.00% 0/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	2.9% 1/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.
Respiratory, thoracic and mediastinal disorders Apparent life threatening event	0.00% 0/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	2.0% 1/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.
Respiratory, thoracic and mediastinal disorders Asphyxia	0.00% 0/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	2.9% 1/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.
Respiratory, thoracic and mediastinal disorders Neonatal asphyxia	0.00% 0/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	2.0% 1/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.
Respiratory, thoracic and mediastinal disorders Neonatal respiratory distress syndrome	0.00% 0/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	2.9% 1/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.00% 0/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	2.0% 1/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.
Respiratory, thoracic and mediastinal disorders Tachipnoea	0.00% 0/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	2.0% 1/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.
Respiratory, thoracic and mediastinal disorders Transient tachypnoea of the newborn	0.00% 0/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	2.9% 1/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.
Surgical and medical procedures Caesarean section	0.00% 0/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	2.9% 1/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.

Other adverse events

Measure	Mothers GBS n=51 participants at risk Pregnant women who received one dose of GBS vaccine.	Mothers Placebo n=35 participants at risk Pregnant women who received one injection of saline solution.	Infants GBS n=51 participants at risk Infants born from mothers who received one dose of GBS vaccine.	Infants Placebo n=35 participants at risk Infants born from mothers who received one injection of saline solution.
Gastrointestinal disorders Haemorrhoids	0.00% 0/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	8.6% 3/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.
Gastrointestinal disorders Nausea	7.8% 4/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	14.3% 5/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.
General disorders Fatigue	29.4% 15/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	28.6% 10/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.
General disorders Injection site erythema	17.6% 9/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	11.4% 4/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.
General disorders Injection site haemorrhage	3.9% 2/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	8.6% 3/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.
General disorders Injection site induration	11.8% 6/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	2.9% 1/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.
General disorders Injection site pain	35.3% 18/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	22.9% 8/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.
General disorders Injection site swelling	7.8% 4/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	2.9% 1/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.
General disorders Malaise	13.7% 7/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	11.4% 4/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.
Infections and infestations Bronchitis	5.9% 3/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.
Infections and infestations Cystitis	3.9% 2/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	5.7% 2/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.
Infections and infestations Nasopharyngitis	5.9% 3/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	8.6% 3/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	5.7% 2/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.
Infections and infestations Urinary tract infection	5.9% 3/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	2.9% 1/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.
Infections and infestations Viral infection	0.00% 0/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	5.7% 2/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.
Musculoskeletal and connective tissue disorders Arthralgia	3.9% 2/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	8.6% 3/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.
Musculoskeletal and connective tissue disorders Myalgia	25.5% 13/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	2.9% 1/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.
Nervous system disorders Headache	15.7% 8/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	28.6% 10/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.
Psychiatric disorders Postpartum depression	2.0% 1/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	5.7% 2/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.
Reproductive system and breast disorders Vaginal haemorrage	2.0% 1/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	5.7% 2/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.
Skin and subcutaneous tissue disorders Rash	2.0% 1/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	5.7% 2/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/51 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.	0.00% 0/35 • Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada). The analysis was done on the Safety Set.

Additional Information

Posting Director

Novartis vaccines

Email: RegistryContactVaccinesUS@novartis.com

Results disclosure agreements

• Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
• Publication restrictions are in place

Restriction type: OTHER