Trial Outcomes & Findings for Study on the Safety and Immunogenicity of Boostrix Vaccine in Pregnant Malian Women and Their Infants (NCT NCT03589768)

Results Overview

SAEs included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required inpatient hospitalization or prolongation or a congenital anomaly/birth defect. All SAEs were reported from time of first study vaccination through approximately 6 months after the first study vaccination

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

399 participants

Primary outcome timeframe

Study Day 1 through Day 180 (6-months post-partum)

Results posted on

2025-05-21

Participant Flow

Participants recruited for this study include pregnant women in their first and second trimesters, 18 to 39 years of age, inclusive, who met all eligibility criteria and were deemed to be in good health. The infants of the pregnant participants were also enrolled and followed from birth to 6 months of age. Participants were enrolled between 24JAN2019 and 03JAN2020.

Participant milestones

Participant milestones
Measure	BOOSTRIX - Maternal 0.5 ml single dose of Tdap (Tetanus, Diphtheria, Acellular Pertussis Vaccine), BOOSTRIX administered intramuscularly to pregnant women at 14 0/7 weeks through 26 6/7 weeks estimated Gestational Age (GA). Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed onto aluminum hydroxide: A sterile isotonic suspension of tetanus and diphtheria toxoids and pertussis antigens adsorbed on Aluminum hydroxide.	Td - Maternal 0.5 ml single dose of Td (Tetanus, Diphtheria Toxoid) administered intramuscularly to pregnant women at 14 0/7 weeks through 26 6/7 weeks estimated GA. Tetanus and Diphtheria Toxoids Adsorbed: Used for active immunization of adults and children 7 years of age and older against diphtheria and tetanus.	BOOSTRIX - Infant 0.5 ml single dose of Tdap (Tetanus, Diphtheria, Acellular Pertussis Vaccine), BOOSTRIX administered intramuscularly to pregnant women at 14 0/7 weeks through 26 6/7 weeks estimated GA. Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed onto aluminum hydroxide: A sterile isotonic suspension of tetanus and diphtheria toxoids and pertussis antigens adsorbed on Aluminum hydroxide.	Td - Infant 0.5 ml single dose of Td (Tetanus, Diphtheria Toxoid) administered intramuscularly to pregnant women at 14 0/7 weeks through 26 6/7 weeks estimated GA. Tetanus and Diphtheria Toxoids Adsorbed: Used for active immunization of adults and children 7 years of age and older against diphtheria and tetanus.
Overall Study STARTED	134	67	131	67
Overall Study COMPLETED	130	67	123	64
Overall Study NOT COMPLETED	4	0	8	3

Reasons for withdrawal

Reasons for withdrawal
Measure	BOOSTRIX - Maternal 0.5 ml single dose of Tdap (Tetanus, Diphtheria, Acellular Pertussis Vaccine), BOOSTRIX administered intramuscularly to pregnant women at 14 0/7 weeks through 26 6/7 weeks estimated Gestational Age (GA). Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed onto aluminum hydroxide: A sterile isotonic suspension of tetanus and diphtheria toxoids and pertussis antigens adsorbed on Aluminum hydroxide.	BOOSTRIX - Infant 0.5 ml single dose of Tdap (Tetanus, Diphtheria, Acellular Pertussis Vaccine), BOOSTRIX administered intramuscularly to pregnant women at 14 0/7 weeks through 26 6/7 weeks estimated GA. Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed onto aluminum hydroxide: A sterile isotonic suspension of tetanus and diphtheria toxoids and pertussis antigens adsorbed on Aluminum hydroxide.	Td - Infant 0.5 ml single dose of Td (Tetanus, Diphtheria Toxoid) administered intramuscularly to pregnant women at 14 0/7 weeks through 26 6/7 weeks estimated GA. Tetanus and Diphtheria Toxoids Adsorbed: Used for active immunization of adults and children 7 years of age and older against diphtheria and tetanus.
Overall Study Death	1	8	3
Overall Study Withdrawal by Subject	2	0	0
Overall Study Protocol Violation	1	0	0

Baseline Characteristics

Ages for each group are represented on separate rows for Mothers and Infants. Infants were enrolled in the study upon birth.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	BOOSTRIX - Maternal n=133 Participants 0.5 ml single dose of Tdap, BOOSTRIX administered intramuscularly to pregnant women at 14 0/7 weeks through 26 6/7 weeks estimated Gestational Age (GA).	Td - Maternal n=67 Participants 0.5 ml single dose of Td administered intramuscularly to pregnant women at 14 0/7 weeks through 26 6/7 weeks estimated GA.	BOOSTRIX - Infant n=126 Participants Infants of pregnant women who received 0.5 ml single dose of Tdap, BOOSTRIX administered intramuscularly to pregnant women at 14 0/7 weeks through 26 6/7 weeks estimated Gestational Age (GA).	Td - Infant n=66 Participants Infants of pregnant women who received 0.5 ml single dose of Td administered intramuscularly to pregnant women at 14 0/7 weeks through 26 6/7 weeks estimated GA.	Total n=392 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=133 Participants	0 Participants n=67 Participants	126 Participants n=126 Participants	66 Participants n=66 Participants	192 Participants n=392 Participants
Age, Categorical Between 18 and 65 years	133 Participants n=133 Participants	67 Participants n=67 Participants	0 Participants n=126 Participants	0 Participants n=66 Participants	200 Participants n=392 Participants
Age, Categorical >=65 years	0 Participants n=133 Participants	0 Participants n=67 Participants	0 Participants n=126 Participants	0 Participants n=66 Participants	0 Participants n=392 Participants
Age, Continuous Mothers	25.7 years STANDARD_DEVIATION 5.6 • n=133 Participants • Ages for each group are represented on separate rows for Mothers and Infants. Infants were enrolled in the study upon birth.	25.4 years STANDARD_DEVIATION 5.4 • n=67 Participants • Ages for each group are represented on separate rows for Mothers and Infants. Infants were enrolled in the study upon birth.	—	—	25.6 years STANDARD_DEVIATION 5.5 • n=200 Participants • Ages for each group are represented on separate rows for Mothers and Infants. Infants were enrolled in the study upon birth.
Age, Continuous Infants	—	—	0 years STANDARD_DEVIATION 0 • n=126 Participants • Ages for each group are represented on separate rows for Mothers and Infants. Infants were enrolled in the study upon birth.	0 years STANDARD_DEVIATION 0 • n=66 Participants • Ages for each group are represented on separate rows for Mothers and Infants. Infants were enrolled in the study upon birth.	0 years STANDARD_DEVIATION 0 • n=192 Participants • Ages for each group are represented on separate rows for Mothers and Infants. Infants were enrolled in the study upon birth.
Sex: Female, Male Female	133 Participants n=133 Participants	67 Participants n=67 Participants	58 Participants n=126 Participants	34 Participants n=66 Participants	292 Participants n=392 Participants
Sex: Female, Male Male	0 Participants n=133 Participants	0 Participants n=67 Participants	68 Participants n=126 Participants	32 Participants n=66 Participants	100 Participants n=392 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=133 Participants	0 Participants n=67 Participants	0 Participants n=126 Participants	0 Participants n=66 Participants	0 Participants n=392 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	133 Participants n=133 Participants	67 Participants n=67 Participants	126 Participants n=126 Participants	66 Participants n=66 Participants	392 Participants n=392 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=133 Participants	0 Participants n=67 Participants	0 Participants n=126 Participants	0 Participants n=66 Participants	0 Participants n=392 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=133 Participants	0 Participants n=67 Participants	0 Participants n=126 Participants	0 Participants n=66 Participants	0 Participants n=392 Participants
Race (NIH/OMB) Asian	0 Participants n=133 Participants	0 Participants n=67 Participants	0 Participants n=126 Participants	0 Participants n=66 Participants	0 Participants n=392 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=133 Participants	0 Participants n=67 Participants	0 Participants n=126 Participants	0 Participants n=66 Participants	0 Participants n=392 Participants
Race (NIH/OMB) Black or African American	133 Participants n=133 Participants	67 Participants n=67 Participants	126 Participants n=126 Participants	66 Participants n=66 Participants	392 Participants n=392 Participants
Race (NIH/OMB) White	0 Participants n=133 Participants	0 Participants n=67 Participants	0 Participants n=126 Participants	0 Participants n=66 Participants	0 Participants n=392 Participants
Race (NIH/OMB) More than one race	0 Participants n=133 Participants	0 Participants n=67 Participants	0 Participants n=126 Participants	0 Participants n=66 Participants	0 Participants n=392 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=133 Participants	0 Participants n=67 Participants	0 Participants n=126 Participants	0 Participants n=66 Participants	0 Participants n=392 Participants
Region of Enrollment Mali	133 participants n=133 Participants	67 participants n=67 Participants	126 participants n=126 Participants	66 participants n=66 Participants	392 participants n=392 Participants
Gestational Age (GA) at Vaccination (weeks) 14-17 weeks	58 Participants n=133 Participants • Gestational Age at Vaccination is only available for participants in the Maternal groups.	35 Participants n=67 Participants • Gestational Age at Vaccination is only available for participants in the Maternal groups.	—	—	93 Participants n=200 Participants • Gestational Age at Vaccination is only available for participants in the Maternal groups.
Gestational Age (GA) at Vaccination (weeks) 18-21 weeks	42 Participants n=133 Participants • Gestational Age at Vaccination is only available for participants in the Maternal groups.	12 Participants n=67 Participants • Gestational Age at Vaccination is only available for participants in the Maternal groups.	—	—	54 Participants n=200 Participants • Gestational Age at Vaccination is only available for participants in the Maternal groups.
Gestational Age (GA) at Vaccination (weeks) 22-26 weeks	33 Participants n=133 Participants • Gestational Age at Vaccination is only available for participants in the Maternal groups.	20 Participants n=67 Participants • Gestational Age at Vaccination is only available for participants in the Maternal groups.	—	—	53 Participants n=200 Participants • Gestational Age at Vaccination is only available for participants in the Maternal groups.

PRIMARY outcome

Timeframe: Study Day 1 through Day 180 (6-months post-partum)

Population: The maternal safety analysis population includes all pregnant women who received the study vaccination

SAEs included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required inpatient hospitalization or prolongation or a congenital anomaly/birth defect. All SAEs were reported from time of first study vaccination through approximately 6 months after the first study vaccination

Outcome measures

Outcome measures
Measure	BOOSTRIX - Maternal n=133 Participants 0.5 ml single dose of Tdap, BOOSTRIX administered intramuscularly to pregnant women at 14 0/7 weeks through 26 6/7 weeks estimated Gestational Age (GA).	Td - Maternal n=67 Participants 0.5 ml single dose of Td administered intramuscularly to pregnant women at 14 0/7 weeks through 26 6/7 weeks estimated GA.
Number of Pregnant Women Reporting Related Serious Adverse Events (SAEs) and Unrelated SAEs Related SAEs	0 Participants	0 Participants
Number of Pregnant Women Reporting Related Serious Adverse Events (SAEs) and Unrelated SAEs Unrelated SAEs	20 Participants	10 Participants

PRIMARY outcome

Timeframe: Study Day 1 through Day 180 (6-months post-partum)

Population: The maternal safety analysis population includes all pregnant women who received the study vaccination.

Pregnancy related AEs include: pregnancy loss (graded as severe \[grade 3\] if occurred), bleeding during pregnancy prior to the onset of labor, postpartum hemorrhage, postabortal endometritis/salpingitis, preterm rupture of membranes, preterm contractions/labor/delivery, poor fetal growth, hypertension, preeclampsia/eclampsia, chorioamnionitis, postpartum endometriosis, gestational diabetes mellitus, and/or pregnancy-related clinical AE not previously identified in this list.

Outcome measures

Outcome measures
Measure	BOOSTRIX - Maternal n=133 Participants 0.5 ml single dose of Tdap, BOOSTRIX administered intramuscularly to pregnant women at 14 0/7 weeks through 26 6/7 weeks estimated Gestational Age (GA).	Td - Maternal n=67 Participants 0.5 ml single dose of Td administered intramuscularly to pregnant women at 14 0/7 weeks through 26 6/7 weeks estimated GA.
Number of Pregnant Women Reporting Pregnancy-Specific Adverse Events (AEs) Mild AEs	5 Participants	1 Participants
Number of Pregnant Women Reporting Pregnancy-Specific Adverse Events (AEs) Moderate AEs	8 Participants	7 Participants
Number of Pregnant Women Reporting Pregnancy-Specific Adverse Events (AEs) Severe AEs	13 Participants	5 Participants

PRIMARY outcome

Timeframe: Birth Day through 6 months of age

Population: The infant safety analysis population includes all infants born during the study via live birth to women who received the study vaccination.

SAEs included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required inpatient hospitalization or prolongation or a congenital anomaly/birth defect. All SAEs were reported from time of birth through 6 months of age.

Outcome measures

Outcome measures
Measure	BOOSTRIX - Maternal n=126 Participants 0.5 ml single dose of Tdap, BOOSTRIX administered intramuscularly to pregnant women at 14 0/7 weeks through 26 6/7 weeks estimated Gestational Age (GA).	Td - Maternal n=66 Participants 0.5 ml single dose of Td administered intramuscularly to pregnant women at 14 0/7 weeks through 26 6/7 weeks estimated GA.
Number of Infants Reporting Related SAEs and Unrelated SAEs Related SAEs	0 Participants	0 Participants
Number of Infants Reporting Related SAEs and Unrelated SAEs Unrelated SAEs	13 Participants	6 Participants

PRIMARY outcome

Timeframe: Birth Day through 6 months of age

Population: The infant safety analysis population includes all infants born during the study via live birth to women who received the study vaccination.

Infant pregnant related AEs include: preterm birth, low birth weight, neonatal complications in a term infant, congenital anomalies/birth defects, and/or clinical AE in the newborn not identified previously in this list.

Outcome measures

Outcome measures
Measure	BOOSTRIX - Maternal n=126 Participants 0.5 ml single dose of Tdap, BOOSTRIX administered intramuscularly to pregnant women at 14 0/7 weeks through 26 6/7 weeks estimated Gestational Age (GA).	Td - Maternal n=66 Participants 0.5 ml single dose of Td administered intramuscularly to pregnant women at 14 0/7 weeks through 26 6/7 weeks estimated GA.
Number of Infants Reporting Pregnancy-specific AEs Mild AEs	0 Participants	0 Participants
Number of Infants Reporting Pregnancy-specific AEs Moderate AEs	15 Participants	5 Participants
Number of Infants Reporting Pregnancy-specific AEs Severe AEs	6 Participants	2 Participants

PRIMARY outcome

Timeframe: Pre-Dose Day 1, Post-Dose Day 1, Day 4, Day 8

Population: The Safety Analysis population includes all pregnant women who received the study vaccination

Local AEs solicited on a memory aid provided to participants included Pain, Tenderness, Ecchymosis (functional grade based on interference with daily activities), Ecchymosis (any measured value \>0mm), Erythema (functional grade), Erythema (any measured value \>0mm), Induration (functional grade), and Induration (any measured value \>0mm). Systemic AEs solicited on a memory aid provided to participants included Elevated Oral Temperature, Feverishness, Fatigue, Malaise, Myalgia, Arthralgia, Headache, Allergic reaction, and Nausea. Participants are considered reporting the local or systemic AE if they reported mild or greater severity at any time during the 8 days at or following the first vaccination.

Outcome measures

Outcome measures
Measure	BOOSTRIX - Maternal n=133 Participants 0.5 ml single dose of Tdap, BOOSTRIX administered intramuscularly to pregnant women at 14 0/7 weeks through 26 6/7 weeks estimated Gestational Age (GA).	Td - Maternal n=67 Participants 0.5 ml single dose of Td administered intramuscularly to pregnant women at 14 0/7 weeks through 26 6/7 weeks estimated GA.
Number of Pregnant Women Reporting Solicited Injection Site and Systemic Reactogenicity Events Pre-Dose	0 Participants	0 Participants
Number of Pregnant Women Reporting Solicited Injection Site and Systemic Reactogenicity Events Post-dose	3 Participants	4 Participants
Number of Pregnant Women Reporting Solicited Injection Site and Systemic Reactogenicity Events Day 4	6 Participants	8 Participants
Number of Pregnant Women Reporting Solicited Injection Site and Systemic Reactogenicity Events Day 8	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Day 1 through Day 31

Population: The maternal safety analysis population includes all pregnant women who received the study vaccination

Frequency of all unsolicited non-serious AEs from day of study vaccination (Day 1) to Day 31, compared between those who received BOOSTRIX and those who received Td.

Outcome measures

Outcome measures
Measure	BOOSTRIX - Maternal n=133 Participants 0.5 ml single dose of Tdap, BOOSTRIX administered intramuscularly to pregnant women at 14 0/7 weeks through 26 6/7 weeks estimated Gestational Age (GA).	Td - Maternal n=67 Participants 0.5 ml single dose of Td administered intramuscularly to pregnant women at 14 0/7 weeks through 26 6/7 weeks estimated GA.
Number of Pregnant Women Reporting Unsolicited Non-serious AEs	6 Participants	2 Participants

PRIMARY outcome

Timeframe: Birth Day, Prior to receipt of first dose of DTwP (approximately 6 weeks of age), One month after receipt of first dose of DTwP (approximately 10 weeks of age), One month after receipt of last dose of DTwP (approximately 18 weeks of age), 6 months of age

Population: The infant mITT population for immunogenicity analyses includes all infants born via live birth to women who received the study vaccination and have a perinatal blood sample for which valid immunogenicity results were reported.

Geometric Mean Concentration (GMC) of serum IgG antibodies to PT as measured by Enzyme-Linked Immunosorbent Assay (ELISA) at birth between infants born to women vaccinated with BOOSTRIX or Td. DTwP is Diphtheria, Tetanus, and whole cell Pertussis vaccine.

Outcome measures

Outcome measures
Measure	BOOSTRIX - Maternal n=124 Participants 0.5 ml single dose of Tdap, BOOSTRIX administered intramuscularly to pregnant women at 14 0/7 weeks through 26 6/7 weeks estimated Gestational Age (GA).	Td - Maternal n=64 Participants 0.5 ml single dose of Td administered intramuscularly to pregnant women at 14 0/7 weeks through 26 6/7 weeks estimated GA.
Geometric Mean Concentration (GMC) of Serum IgG Antibodies to Pertussis Toxin (PT) in Infants Born to Women Receiving BOOSTRIX or Td At birth	55.4 IU/mL Interval 46.2 to 66.6	7.9 IU/mL Interval 5.4 to 11.5
Geometric Mean Concentration (GMC) of Serum IgG Antibodies to Pertussis Toxin (PT) in Infants Born to Women Receiving BOOSTRIX or Td Prior to receipt of first dose of DTwP (approximately 6 weeks of age)	21.0 IU/mL Interval 17.3 to 25.5	4.3 IU/mL Interval 3.0 to 6.2
Geometric Mean Concentration (GMC) of Serum IgG Antibodies to Pertussis Toxin (PT) in Infants Born to Women Receiving BOOSTRIX or Td One month after receipt of first dose of DTwP (approximately 10 weeks of age)	15.0 IU/mL Interval 11.4 to 19.7	5.1 IU/mL Interval 3.3 to 8.1
Geometric Mean Concentration (GMC) of Serum IgG Antibodies to Pertussis Toxin (PT) in Infants Born to Women Receiving BOOSTRIX or Td One month after receipt of last dose of DTwP (approximately 18 weeks of age)	20.2 IU/mL Interval 13.7 to 29.9	77.2 IU/mL Interval 32.2 to 184.8
Geometric Mean Concentration (GMC) of Serum IgG Antibodies to Pertussis Toxin (PT) in Infants Born to Women Receiving BOOSTRIX or Td 6 months of age	17.3 IU/mL Interval 12.8 to 23.4	67.1 IU/mL Interval 35.5 to 126.7

SECONDARY outcome

Timeframe: Pre-dose Day 1, One month after vaccination, at delivery, Day 180 (approximately 6 months after delivery)

Population: The maternal mITT population for immunogenicity analyses includes all pregnant women who received the study vaccination, have valid immunogenicity results (from blood or breastmilk) at baseline, and at least one post-vaccination visit.

GMC of serum IgG antibodies to PT as measured by Enzyme-Linked Immunosorbent Assay (ELISA) between women vaccinated with BOOSTRIX or Td.

Outcome measures

Outcome measures
Measure	BOOSTRIX - Maternal n=130 Participants 0.5 ml single dose of Tdap, BOOSTRIX administered intramuscularly to pregnant women at 14 0/7 weeks through 26 6/7 weeks estimated Gestational Age (GA).	Td - Maternal n=66 Participants 0.5 ml single dose of Td administered intramuscularly to pregnant women at 14 0/7 weeks through 26 6/7 weeks estimated GA.
GMC of Serum IgG Antibodies to PT in Pregnant Women Receiving BOOSTRIX or Td Pre-vaccination	9.1 IU/mL Interval 7.5 to 11.1	9.8 IU/mL Interval 7.3 to 13.1
GMC of Serum IgG Antibodies to PT in Pregnant Women Receiving BOOSTRIX or Td One month after vaccination	90.0 IU/mL Interval 76.8 to 105.6	10.4 IU/mL Interval 7.8 to 13.9
GMC of Serum IgG Antibodies to PT in Pregnant Women Receiving BOOSTRIX or Td Delivery	47.0 IU/mL Interval 40.1 to 55.1	10.1 IU/mL Interval 7.4 to 13.6
GMC of Serum IgG Antibodies to PT in Pregnant Women Receiving BOOSTRIX or Td 6 months after delivery	40.9 IU/mL Interval 33.3 to 50.2	12.2 IU/mL Interval 8.2 to 18.2

SECONDARY outcome

Timeframe: Pre-dose Day 1, One month after vaccination, at delivery, Day 180 (approximately 6 months after delivery)

Population: The maternal mITT population for immunogenicity analyses includes all pregnant women who received the study vaccination, have valid immunogenicity results (from blood or breastmilk) at baseline, and at least one post-vaccination visit.

GMC of serum IgG antibodies to FHA as measured by Enzyme-Linked Immunosorbent Assay (ELISA) between women vaccinated with BOOSTRIX or Td.

Outcome measures

Outcome measures
Measure	BOOSTRIX - Maternal n=130 Participants 0.5 ml single dose of Tdap, BOOSTRIX administered intramuscularly to pregnant women at 14 0/7 weeks through 26 6/7 weeks estimated Gestational Age (GA).	Td - Maternal n=66 Participants 0.5 ml single dose of Td administered intramuscularly to pregnant women at 14 0/7 weeks through 26 6/7 weeks estimated GA.
GMC of Serum IgG Antibodies to Filamentous Hemagglutinin (FHA) in Pregnant Women Receiving BOOSTRIX or Td Pre-vaccination	28.6 IU/mL Interval 24.4 to 33.6	27.1 IU/mL Interval 21.5 to 34.2
GMC of Serum IgG Antibodies to Filamentous Hemagglutinin (FHA) in Pregnant Women Receiving BOOSTRIX or Td One month after vaccination	545.3 IU/mL Interval 463.6 to 641.4	29.5 IU/mL Interval 23.7 to 36.8
GMC of Serum IgG Antibodies to Filamentous Hemagglutinin (FHA) in Pregnant Women Receiving BOOSTRIX or Td Delivery	321.5 IU/mL Interval 275.0 to 375.8	30.6 IU/mL Interval 24.8 to 37.7
GMC of Serum IgG Antibodies to Filamentous Hemagglutinin (FHA) in Pregnant Women Receiving BOOSTRIX or Td 6 months after delivery	259.0 IU/mL Interval 205.3 to 326.6	34.9 IU/mL Interval 24.7 to 49.3

SECONDARY outcome

Timeframe: Pre-dose Day 1, One month after vaccination, at delivery, Day 180 (approximately 6 months after delivery)

Population: The maternal mITT population for immunogenicity analyses includes all pregnant women who received the study vaccination, have valid immunogenicity results (from blood or breastmilk) at baseline, and at least one post-vaccination visit.

GMC of serum IgG antibodies to PRN as measured by Enzyme-Linked Immunosorbent Assay (ELISA) between women vaccinated with BOOSTRIX or Td.

Outcome measures

Outcome measures
Measure	BOOSTRIX - Maternal n=130 Participants 0.5 ml single dose of Tdap, BOOSTRIX administered intramuscularly to pregnant women at 14 0/7 weeks through 26 6/7 weeks estimated Gestational Age (GA).	Td - Maternal n=66 Participants 0.5 ml single dose of Td administered intramuscularly to pregnant women at 14 0/7 weeks through 26 6/7 weeks estimated GA.
GMC of Serum IgG Antibodies to Pertactin (PRN) in Pregnant Women Receiving BOOSTRIX or Td Pre-vaccination	5.6 IU/mL Interval 4.4 to 6.9	4.6 IU/mL Interval 3.5 to 6.0
GMC of Serum IgG Antibodies to Pertactin (PRN) in Pregnant Women Receiving BOOSTRIX or Td One month after vaccination	255.3 IU/mL Interval 186.4 to 349.9	4.7 IU/mL Interval 3.6 to 6.2
GMC of Serum IgG Antibodies to Pertactin (PRN) in Pregnant Women Receiving BOOSTRIX or Td Delivery	164.6 IU/mL Interval 121.0 to 224.1	5.1 IU/mL Interval 3.7 to 7.1
GMC of Serum IgG Antibodies to Pertactin (PRN) in Pregnant Women Receiving BOOSTRIX or Td 6 months after delivery	97.1 IU/mL Interval 61.5 to 153.5	5.1 IU/mL Interval 3.5 to 7.6

SECONDARY outcome

Timeframe: Pre-dose Day 1, One month after vaccination, at delivery, Day 180 (approximately 6 months after delivery)

Population: The maternal mITT population for immunogenicity analyses includes all pregnant women who received the study vaccination, have valid immunogenicity results (from blood or breastmilk) at baseline, and at least one post-vaccination visit.

GMC of serum IgG antibodies to Tetanus as measured by Enzyme-Linked Immunosorbent Assay (ELISA) between women vaccinated with BOOSTRIX or Td.

Outcome measures

Outcome measures
Measure	BOOSTRIX - Maternal n=130 Participants 0.5 ml single dose of Tdap, BOOSTRIX administered intramuscularly to pregnant women at 14 0/7 weeks through 26 6/7 weeks estimated Gestational Age (GA).	Td - Maternal n=66 Participants 0.5 ml single dose of Td administered intramuscularly to pregnant women at 14 0/7 weeks through 26 6/7 weeks estimated GA.
GMC of Serum IgG Antibodies to Tetanus in Pregnant Women Receiving BOOSTRIX or Td Pre-vaccination	1.3 IU/mL Interval 1.0 to 1.7	1.3 IU/mL Interval 0.9 to 1.9
GMC of Serum IgG Antibodies to Tetanus in Pregnant Women Receiving BOOSTRIX or Td One month after vaccination	6.6 IU/mL Interval 5.8 to 7.4	10.4 IU/mL Interval 8.8 to 12.2
GMC of Serum IgG Antibodies to Tetanus in Pregnant Women Receiving BOOSTRIX or Td Delivery	3.3 IU/mL Interval 2.9 to 3.8	4.6 IU/mL Interval 3.9 to 5.5
GMC of Serum IgG Antibodies to Tetanus in Pregnant Women Receiving BOOSTRIX or Td 6 months after delivery	2.9 IU/mL Interval 2.3 to 3.6	3.8 IU/mL Interval 3.1 to 4.5

SECONDARY outcome

Timeframe: Pre-dose Day 1, One month after vaccination, at delivery, Day 180 (approximately 6 months after delivery)

Population: The maternal mITT population for immunogenicity analyses includes all pregnant women who received the study vaccination, have valid immunogenicity results (from blood or breastmilk) at baseline, and at least one post-vaccination visit.

GMC of serum IgG antibodies to Diphtheria as measured by Enzyme-Linked Immunosorbent Assay (ELISA) between women vaccinated with BOOSTRIX or Td.

Outcome measures

Outcome measures
Measure	BOOSTRIX - Maternal n=130 Participants 0.5 ml single dose of Tdap, BOOSTRIX administered intramuscularly to pregnant women at 14 0/7 weeks through 26 6/7 weeks estimated Gestational Age (GA).	Td - Maternal n=66 Participants 0.5 ml single dose of Td administered intramuscularly to pregnant women at 14 0/7 weeks through 26 6/7 weeks estimated GA.
GMC of Serum IgG Antibodies to Diphtheria in Pregnant Women Receiving BOOSTRIX or Td Pre-vaccination	0.2 IU/mL Interval 0.1 to 0.2	0.2 IU/mL Interval 0.1 to 0.2
GMC of Serum IgG Antibodies to Diphtheria in Pregnant Women Receiving BOOSTRIX or Td One month after vaccination	1.3 IU/mL Interval 1.1 to 1.6	1.5 IU/mL Interval 1.1 to 2.0
GMC of Serum IgG Antibodies to Diphtheria in Pregnant Women Receiving BOOSTRIX or Td Delivery	0.8 IU/mL Interval 0.6 to 0.9	0.9 IU/mL Interval 0.6 to 1.2
GMC of Serum IgG Antibodies to Diphtheria in Pregnant Women Receiving BOOSTRIX or Td 6 months after delivery	0.6 IU/mL Interval 0.5 to 0.9	0.9 IU/mL Interval 0.6 to 1.4

SECONDARY outcome

Timeframe: Birth Day, Prior to receipt of first dose of DTwP (approximately 6 weeks of age), One month after receipt of first dose of DTwP (approximately 10 weeks of age), One month after receipt of last dose of DTwP (approximately 18 weeks of age), 6 months of age

Population: The infant mITT population for immunogenicity analyses includes all infants born via live birth to women who received the study vaccination and have a perinatal blood sample for which valid immunogenicity results were reported.

GMC of serum IgG antibodies to FHA as measured by Enzyme-Linked Immunosorbent Assay (ELISA) at birth between infants born to women vaccinated with BOOSTRIX or Td.

Outcome measures

Outcome measures
Measure	BOOSTRIX - Maternal n=124 Participants 0.5 ml single dose of Tdap, BOOSTRIX administered intramuscularly to pregnant women at 14 0/7 weeks through 26 6/7 weeks estimated Gestational Age (GA).	Td - Maternal n=64 Participants 0.5 ml single dose of Td administered intramuscularly to pregnant women at 14 0/7 weeks through 26 6/7 weeks estimated GA.
GMC of Serum IgG Antibodies to FHA in Infants Born to Women Receiving BOOSTRIX or Td At birth	387.5 IU/mL Interval 327.9 to 457.9	28.4 IU/mL Interval 22.2 to 36.3
GMC of Serum IgG Antibodies to FHA in Infants Born to Women Receiving BOOSTRIX or Td Prior to receipt of first dose of DTwP (approximately 6 weeks of age)	143.5 IU/mL Interval 121.8 to 169.1	13.3 IU/mL Interval 10.1 to 17.6
GMC of Serum IgG Antibodies to FHA in Infants Born to Women Receiving BOOSTRIX or Td One month after receipt of first dose of DTwP (approximately 10 weeks of age)	89.4 IU/mL Interval 70.7 to 113.2	8.7 IU/mL Interval 6.2 to 12.3
GMC of Serum IgG Antibodies to FHA in Infants Born to Women Receiving BOOSTRIX or Td One month after receipt of last dose of DTwP (approximately 18 weeks of age)	46.2 IU/mL Interval 37.8 to 56.4	22.5 IU/mL Interval 15.9 to 31.7
GMC of Serum IgG Antibodies to FHA in Infants Born to Women Receiving BOOSTRIX or Td 6 months of age	23.9 IU/mL Interval 19.2 to 29.8	20.7 IU/mL Interval 14.2 to 30.2

SECONDARY outcome

Timeframe: Birth Day, Prior to receipt of first dose of DTwP (approximately 6 weeks of age), One month after receipt of first dose of DTwP (approximately 10 weeks of age), One month after receipt of last dose of DTwP (approximately 18 weeks of age), 6 months of age

Population: The infant mITT population for immunogenicity analyses includes all infants born via live birth to women who received the study vaccination and have a perinatal blood sample for which valid immunogenicity results were reported.

GMC of serum IgG antibodies to PRN as measured by Enzyme-Linked Immunosorbent Assay (ELISA) at birth between infants born to women vaccinated with BOOSTRIX or Td.

Outcome measures

Outcome measures
Measure	BOOSTRIX - Maternal n=124 Participants 0.5 ml single dose of Tdap, BOOSTRIX administered intramuscularly to pregnant women at 14 0/7 weeks through 26 6/7 weeks estimated Gestational Age (GA).	Td - Maternal n=64 Participants 0.5 ml single dose of Td administered intramuscularly to pregnant women at 14 0/7 weeks through 26 6/7 weeks estimated GA.
GMC of Serum IgG Antibodies to PRN in Infants Born to Women Receiving BOOSTRIX or Td 6 months of age	28.4 IU/mL Interval 21.6 to 37.3	39.1 IU/mL Interval 28.2 to 54.2
GMC of Serum IgG Antibodies to PRN in Infants Born to Women Receiving BOOSTRIX or Td At birth	184.5 IU/mL Interval 130.6 to 260.6	4.0 IU/mL Interval 2.7 to 5.9
GMC of Serum IgG Antibodies to PRN in Infants Born to Women Receiving BOOSTRIX or Td Prior to receipt of first dose of DTwP (approximately 6 weeks of age)	72.6 IU/mL Interval 51.7 to 101.9	1.8 IU/mL Interval 1.3 to 2.7
GMC of Serum IgG Antibodies to PRN in Infants Born to Women Receiving BOOSTRIX or Td One month after receipt of first dose of DTwP (approximately 10 weeks of age)	47.1 IU/mL Interval 33.2 to 66.8	4.5 IU/mL Interval 3.1 to 6.6
GMC of Serum IgG Antibodies to PRN in Infants Born to Women Receiving BOOSTRIX or Td One month after receipt of last dose of DTwP (approximately 18 weeks of age)	48.6 IU/mL Interval 34.9 to 67.8	80.2 IU/mL Interval 52.2 to 123.1

SECONDARY outcome

Timeframe: Birth Day, Prior to receipt of first dose of DTwP (approximately 6 weeks of age), One month after receipt of first dose of DTwP (approximately 10 weeks of age), One month after receipt of last dose of DTwP (approximately 18 weeks of age), 6 months of age

Population: The infant mITT population for immunogenicity analyses includes all infants born via live birth to women who received the study vaccination and have a perinatal blood sample for which valid immunogenicity results were reported.

GMC of serum IgG antibodies to Tetanus as measured by Enzyme-Linked Immunosorbent Assay (ELISA) at birth between infants born to women vaccinated with BOOSTRIX or Td.

Outcome measures

Outcome measures
Measure	BOOSTRIX - Maternal n=124 Participants 0.5 ml single dose of Tdap, BOOSTRIX administered intramuscularly to pregnant women at 14 0/7 weeks through 26 6/7 weeks estimated Gestational Age (GA).	Td - Maternal n=64 Participants 0.5 ml single dose of Td administered intramuscularly to pregnant women at 14 0/7 weeks through 26 6/7 weeks estimated GA.
GMC of Serum IgG Antibodies to Tetanus in Infants Born to Women Receiving BOOSTRIX or Td At birth	4.1 IU/mL Interval 3.5 to 4.8	5.9 IU/mL Interval 5.0 to 7.0
GMC of Serum IgG Antibodies to Tetanus in Infants Born to Women Receiving BOOSTRIX or Td Prior to receipt of first dose of DTwP (approximately 6 weeks of age)	1.4 IU/mL Interval 1.2 to 1.6	2.0 IU/mL Interval 1.7 to 2.4
GMC of Serum IgG Antibodies to Tetanus in Infants Born to Women Receiving BOOSTRIX or Td One month after receipt of first dose of DTwP (approximately 10 weeks of age)	0.8 IU/mL Interval 0.6 to 0.9	1.1 IU/mL Interval 0.9 to 1.3
GMC of Serum IgG Antibodies to Tetanus in Infants Born to Women Receiving BOOSTRIX or Td One month after receipt of last dose of DTwP (approximately 18 weeks of age)	0.9 IU/mL Interval 0.6 to 1.2	1.5 IU/mL Interval 0.9 to 2.4
GMC of Serum IgG Antibodies to Tetanus in Infants Born to Women Receiving BOOSTRIX or Td 6 months of age	0.8 IU/mL Interval 0.6 to 1.1	1.0 IU/mL Interval 0.7 to 1.4

SECONDARY outcome

Timeframe: Birth Day, Prior to receipt of first dose of DTwP (approximately 6 weeks of age), One month after receipt of first dose of DTwP (approximately 10 weeks of age), One month after receipt of last dose of DTwP (approximately 18 weeks of age), 6 months of age

Population: The infant mITT population for immunogenicity analyses includes all infants born via live birth to women who received the study vaccination and have a perinatal blood sample for which valid immunogenicity results were reported.

GMC of serum IgG antibodies to Diphtheria as measured by Enzyme-Linked Immunosorbent Assay (ELISA) at birth between infants born to women vaccinated with BOOSTRIX or Td.

Outcome measures

Outcome measures
Measure	BOOSTRIX - Maternal n=124 Participants 0.5 ml single dose of Tdap, BOOSTRIX administered intramuscularly to pregnant women at 14 0/7 weeks through 26 6/7 weeks estimated Gestational Age (GA).	Td - Maternal n=64 Participants 0.5 ml single dose of Td administered intramuscularly to pregnant women at 14 0/7 weeks through 26 6/7 weeks estimated GA.
GMC of Serum IgG Antibodies to Diphtheria in Infants Born to Women Receiving BOOSTRIX or Td 6 months of age	0.2 IU/mL Interval 0.1 to 0.2	0.1 IU/mL Interval 0.1 to 0.2
GMC of Serum IgG Antibodies to Diphtheria in Infants Born to Women Receiving BOOSTRIX or Td At birth	0.8 IU/mL Interval 0.7 to 1.0	0.9 IU/mL Interval 0.7 to 1.3
GMC of Serum IgG Antibodies to Diphtheria in Infants Born to Women Receiving BOOSTRIX or Td Prior to receipt of first dose of DTwP (approximately 6 weeks of age)	0.3 IU/mL Interval 0.2 to 0.4	0.3 IU/mL Interval 0.2 to 0.4
GMC of Serum IgG Antibodies to Diphtheria in Infants Born to Women Receiving BOOSTRIX or Td One month after receipt of first dose of DTwP (approximately 10 weeks of age)	0.2 IU/mL Interval 0.1 to 0.3	0.2 IU/mL Interval 0.1 to 0.3
GMC of Serum IgG Antibodies to Diphtheria in Infants Born to Women Receiving BOOSTRIX or Td One month after receipt of last dose of DTwP (approximately 18 weeks of age)	0.2 IU/mL Interval 0.2 to 0.3	0.4 IU/mL Interval 0.2 to 0.6

SECONDARY outcome

Timeframe: Birth Day, Prior to receipt of first dose of DTwP (approximately 6 weeks of age), One month after receipt of first dose of DTwP (approximately 10 weeks of age), One month after receipt of last dose of DTwP (approximately 18 weeks of age), 6 months of age

Population: The infant mITT population for immunogenicity analyses includes all infants born via live birth to women who received the study vaccination and have a perinatal blood sample for which valid immunogenicity results were reported.

GMC of serum IgG antibodies to FIM 2/3 as measured by Enzyme-Linked Immunosorbent Assay (ELISA) at birth between infants born to women vaccinated with BOOSTRIX or Td.

Outcome measures

Outcome measures
Measure	BOOSTRIX - Maternal n=124 Participants 0.5 ml single dose of Tdap, BOOSTRIX administered intramuscularly to pregnant women at 14 0/7 weeks through 26 6/7 weeks estimated Gestational Age (GA).	Td - Maternal n=64 Participants 0.5 ml single dose of Td administered intramuscularly to pregnant women at 14 0/7 weeks through 26 6/7 weeks estimated GA.
GMC of Serum IgG Antibodies to Fimbriae 2/3 (FIM 2/3) in Infants Born to Women Receiving BOOSTRIX or Td At birth	23.9 IU/mL Interval 17.8 to 32.0	15.2 IU/mL Interval 9.8 to 23.8
GMC of Serum IgG Antibodies to Fimbriae 2/3 (FIM 2/3) in Infants Born to Women Receiving BOOSTRIX or Td Prior to receipt of first dose of DTwP (approximately 6 weeks of age)	9.5 IU/mL Interval 7.1 to 12.7	6.9 IU/mL Interval 4.5 to 10.4
GMC of Serum IgG Antibodies to Fimbriae 2/3 (FIM 2/3) in Infants Born to Women Receiving BOOSTRIX or Td One month after receipt of first dose of DTwP (approximately 10 weeks of age)	10.9 IU/mL Interval 7.8 to 15.3	6.8 IU/mL Interval 4.8 to 9.7
GMC of Serum IgG Antibodies to Fimbriae 2/3 (FIM 2/3) in Infants Born to Women Receiving BOOSTRIX or Td One month after receipt of last dose of DTwP (approximately 18 weeks of age)	254.0 IU/mL Interval 153.3 to 420.6	517.6 IU/mL Interval 292.2 to 916.8
GMC of Serum IgG Antibodies to Fimbriae 2/3 (FIM 2/3) in Infants Born to Women Receiving BOOSTRIX or Td 6 months of age	274.3 IU/mL Interval 191.7 to 392.6	465.6 IU/mL Interval 316.7 to 684.6

SECONDARY outcome

Timeframe: Time of delivery

Population: The infant mITT population for immunogenicity analyses includes all infants born via live birth to women who received the study vaccination and have a perinatal blood sample for which valid immunogenicity results were reported.

GMR of maternal and infant-specific Tdap-specific antibodies (PT, FHA, PRN, tetanus, diphtheria) as measured by ELISA at delivery/birth after intrapartum receipt of BOOSTRIX versus Td. GMR represents the geometric mean ratio in infant antibody concentration at birth to maternal antibody concentration at delivery.

Outcome measures

Outcome measures
Measure	BOOSTRIX - Maternal n=124 Participants 0.5 ml single dose of Tdap, BOOSTRIX administered intramuscularly to pregnant women at 14 0/7 weeks through 26 6/7 weeks estimated Gestational Age (GA).	Td - Maternal n=64 Participants 0.5 ml single dose of Td administered intramuscularly to pregnant women at 14 0/7 weeks through 26 6/7 weeks estimated GA.
Geometric Mean Ratio (GMR) of Maternal and Infant-specific Tdap-specific Antibodies Pertussis Toxin (PT)	1.2 ratio Interval 1.1 to 1.2	0.8 ratio Interval 0.7 to 0.9
Geometric Mean Ratio (GMR) of Maternal and Infant-specific Tdap-specific Antibodies Filamentous Hemagluttin (FHA)	1.2 ratio Interval 1.2 to 1.3	0.9 ratio Interval 0.8 to 1.0
Geometric Mean Ratio (GMR) of Maternal and Infant-specific Tdap-specific Antibodies Pertactin (PRN)	1.1 ratio Interval 1.1 to 1.2	0.8 ratio Interval 0.7 to 0.9
Geometric Mean Ratio (GMR) of Maternal and Infant-specific Tdap-specific Antibodies Tetanus	1.2 ratio Interval 1.2 to 1.3	1.3 ratio Interval 1.2 to 1.3
Geometric Mean Ratio (GMR) of Maternal and Infant-specific Tdap-specific Antibodies Diphtheria	1.1 ratio Interval 1.0 to 1.1	1.1 ratio Interval 1.0 to 1.1

Adverse Events

BOOSTRIX - Maternal

Serious events: 20 serious events

Other events: 35 other events

Deaths: 1 deaths

Td - Maternal

Serious events: 10 serious events

Other events: 24 other events

Deaths: 0 deaths

BOOSTRIX - Infant

Serious events: 13 serious events

Other events: 0 other events

Deaths: 8 deaths

Td - Infant

Serious events: 6 serious events

Other events: 0 other events

Deaths: 3 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	BOOSTRIX - Maternal n=133 participants at risk 0.5 ml single dose of Tdap, BOOSTRIX administered intramuscularly to pregnant women at 14 0/7 weeks through 26 6/7 weeks estimated Gestational Age (GA).	Td - Maternal n=67 participants at risk 0.5 ml single dose of Td administered intramuscularly to pregnant women at 14 0/7 weeks through 26 6/7 weeks estimated GA.	BOOSTRIX - Infant n=126 participants at risk Infants of pregnant women who received 0.5 ml single dose of Tdap, BOOSTRIX administered intramuscularly to pregnant women at 14 0/7 weeks through 26 6/7 weeks estimated Gestational Age (GA).	Td - Infant n=66 participants at risk Infants of pregnant women who received 0.5 ml single dose of Td administered intramuscularly to pregnant women at 14 0/7 weeks through 26 6/7 weeks estimated GA.
General disorders Injection site pain	6.8% 9/133 • Number of events 9 • Study vaccine-related Serious Adverse Events (SAE) occurring from the time of study vaccination through 6 months postpartum (180 days of life for the infant visit) for pregnant participants and infants were collected. Solicited Adverse Events (AEs) were collected from time of study vaccination through 7 days after study vaccination (Day 8). Unsolicited non-serious AEs were collected from time of study vaccination through approximately 30 days after study vaccination (Day 31). Total number of participants At Risk includes all maternal participants who received the study vaccine or infants born to mothers who received the study vaccine.	14.9% 10/67 • Number of events 10 • Study vaccine-related Serious Adverse Events (SAE) occurring from the time of study vaccination through 6 months postpartum (180 days of life for the infant visit) for pregnant participants and infants were collected. Solicited Adverse Events (AEs) were collected from time of study vaccination through 7 days after study vaccination (Day 8). Unsolicited non-serious AEs were collected from time of study vaccination through approximately 30 days after study vaccination (Day 31). Total number of participants At Risk includes all maternal participants who received the study vaccine or infants born to mothers who received the study vaccine.	0.00% 0/126 • Study vaccine-related Serious Adverse Events (SAE) occurring from the time of study vaccination through 6 months postpartum (180 days of life for the infant visit) for pregnant participants and infants were collected. Solicited Adverse Events (AEs) were collected from time of study vaccination through 7 days after study vaccination (Day 8). Unsolicited non-serious AEs were collected from time of study vaccination through approximately 30 days after study vaccination (Day 31). Total number of participants At Risk includes all maternal participants who received the study vaccine or infants born to mothers who received the study vaccine.	0.00% 0/66 • Study vaccine-related Serious Adverse Events (SAE) occurring from the time of study vaccination through 6 months postpartum (180 days of life for the infant visit) for pregnant participants and infants were collected. Solicited Adverse Events (AEs) were collected from time of study vaccination through 7 days after study vaccination (Day 8). Unsolicited non-serious AEs were collected from time of study vaccination through approximately 30 days after study vaccination (Day 31). Total number of participants At Risk includes all maternal participants who received the study vaccine or infants born to mothers who received the study vaccine.
Investigations Blood pressure diastolic increased	15.0% 20/133 • Number of events 21 • Study vaccine-related Serious Adverse Events (SAE) occurring from the time of study vaccination through 6 months postpartum (180 days of life for the infant visit) for pregnant participants and infants were collected. Solicited Adverse Events (AEs) were collected from time of study vaccination through 7 days after study vaccination (Day 8). Unsolicited non-serious AEs were collected from time of study vaccination through approximately 30 days after study vaccination (Day 31). Total number of participants At Risk includes all maternal participants who received the study vaccine or infants born to mothers who received the study vaccine.	16.4% 11/67 • Number of events 12 • Study vaccine-related Serious Adverse Events (SAE) occurring from the time of study vaccination through 6 months postpartum (180 days of life for the infant visit) for pregnant participants and infants were collected. Solicited Adverse Events (AEs) were collected from time of study vaccination through 7 days after study vaccination (Day 8). Unsolicited non-serious AEs were collected from time of study vaccination through approximately 30 days after study vaccination (Day 31). Total number of participants At Risk includes all maternal participants who received the study vaccine or infants born to mothers who received the study vaccine.	0.00% 0/126 • Study vaccine-related Serious Adverse Events (SAE) occurring from the time of study vaccination through 6 months postpartum (180 days of life for the infant visit) for pregnant participants and infants were collected. Solicited Adverse Events (AEs) were collected from time of study vaccination through 7 days after study vaccination (Day 8). Unsolicited non-serious AEs were collected from time of study vaccination through approximately 30 days after study vaccination (Day 31). Total number of participants At Risk includes all maternal participants who received the study vaccine or infants born to mothers who received the study vaccine.	0.00% 0/66 • Study vaccine-related Serious Adverse Events (SAE) occurring from the time of study vaccination through 6 months postpartum (180 days of life for the infant visit) for pregnant participants and infants were collected. Solicited Adverse Events (AEs) were collected from time of study vaccination through 7 days after study vaccination (Day 8). Unsolicited non-serious AEs were collected from time of study vaccination through approximately 30 days after study vaccination (Day 31). Total number of participants At Risk includes all maternal participants who received the study vaccine or infants born to mothers who received the study vaccine.
Investigations Blood pressure systolic increased	5.3% 7/133 • Number of events 7 • Study vaccine-related Serious Adverse Events (SAE) occurring from the time of study vaccination through 6 months postpartum (180 days of life for the infant visit) for pregnant participants and infants were collected. Solicited Adverse Events (AEs) were collected from time of study vaccination through 7 days after study vaccination (Day 8). Unsolicited non-serious AEs were collected from time of study vaccination through approximately 30 days after study vaccination (Day 31). Total number of participants At Risk includes all maternal participants who received the study vaccine or infants born to mothers who received the study vaccine.	3.0% 2/67 • Number of events 3 • Study vaccine-related Serious Adverse Events (SAE) occurring from the time of study vaccination through 6 months postpartum (180 days of life for the infant visit) for pregnant participants and infants were collected. Solicited Adverse Events (AEs) were collected from time of study vaccination through 7 days after study vaccination (Day 8). Unsolicited non-serious AEs were collected from time of study vaccination through approximately 30 days after study vaccination (Day 31). Total number of participants At Risk includes all maternal participants who received the study vaccine or infants born to mothers who received the study vaccine.	0.00% 0/126 • Study vaccine-related Serious Adverse Events (SAE) occurring from the time of study vaccination through 6 months postpartum (180 days of life for the infant visit) for pregnant participants and infants were collected. Solicited Adverse Events (AEs) were collected from time of study vaccination through 7 days after study vaccination (Day 8). Unsolicited non-serious AEs were collected from time of study vaccination through approximately 30 days after study vaccination (Day 31). Total number of participants At Risk includes all maternal participants who received the study vaccine or infants born to mothers who received the study vaccine.	0.00% 0/66 • Study vaccine-related Serious Adverse Events (SAE) occurring from the time of study vaccination through 6 months postpartum (180 days of life for the infant visit) for pregnant participants and infants were collected. Solicited Adverse Events (AEs) were collected from time of study vaccination through 7 days after study vaccination (Day 8). Unsolicited non-serious AEs were collected from time of study vaccination through approximately 30 days after study vaccination (Day 31). Total number of participants At Risk includes all maternal participants who received the study vaccine or infants born to mothers who received the study vaccine.
Investigations Heart rate increased	7.5% 10/133 • Number of events 10 • Study vaccine-related Serious Adverse Events (SAE) occurring from the time of study vaccination through 6 months postpartum (180 days of life for the infant visit) for pregnant participants and infants were collected. Solicited Adverse Events (AEs) were collected from time of study vaccination through 7 days after study vaccination (Day 8). Unsolicited non-serious AEs were collected from time of study vaccination through approximately 30 days after study vaccination (Day 31). Total number of participants At Risk includes all maternal participants who received the study vaccine or infants born to mothers who received the study vaccine.	9.0% 6/67 • Number of events 6 • Study vaccine-related Serious Adverse Events (SAE) occurring from the time of study vaccination through 6 months postpartum (180 days of life for the infant visit) for pregnant participants and infants were collected. Solicited Adverse Events (AEs) were collected from time of study vaccination through 7 days after study vaccination (Day 8). Unsolicited non-serious AEs were collected from time of study vaccination through approximately 30 days after study vaccination (Day 31). Total number of participants At Risk includes all maternal participants who received the study vaccine or infants born to mothers who received the study vaccine.	0.00% 0/126 • Study vaccine-related Serious Adverse Events (SAE) occurring from the time of study vaccination through 6 months postpartum (180 days of life for the infant visit) for pregnant participants and infants were collected. Solicited Adverse Events (AEs) were collected from time of study vaccination through 7 days after study vaccination (Day 8). Unsolicited non-serious AEs were collected from time of study vaccination through approximately 30 days after study vaccination (Day 31). Total number of participants At Risk includes all maternal participants who received the study vaccine or infants born to mothers who received the study vaccine.	0.00% 0/66 • Study vaccine-related Serious Adverse Events (SAE) occurring from the time of study vaccination through 6 months postpartum (180 days of life for the infant visit) for pregnant participants and infants were collected. Solicited Adverse Events (AEs) were collected from time of study vaccination through 7 days after study vaccination (Day 8). Unsolicited non-serious AEs were collected from time of study vaccination through approximately 30 days after study vaccination (Day 31). Total number of participants At Risk includes all maternal participants who received the study vaccine or infants born to mothers who received the study vaccine.

Additional Information

Kathleen M. Neuzil, MD, MPH

University of Maryland School of Medicine

Phone: 410-706-5328

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60