Trial Outcomes & Findings for Prevention of GBS Colonization Via Immunity (NCT NCT00128219)

Results Overview

Time to first acquisition of vaginal type III GBS was calculated as time from vaccination to the mid-point of the interval of ascertainment, censored by either the end of the follow-up period, or the first of 2 or more consecutive missed visits. Vaginal type III GBS status at missed visits prior to censoring was imputed from the subsequent visit.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

667 participants

Primary outcome timeframe

Time from vaccination to acquisition of vaginal type III GBS, up to 18 months post-vaccination.

Results posted on

2015-01-27

Participant Flow

Young (ages 18 through 40), sexually active (sex at least once in the last 4 months), non-pregnant women from the surrounding communities and who were negative for vaginal and rectal colonization with type III group B streptococcus (GBS) were offered enrollment, between July 7, 2003 and August 8, 2006

Participants were screened for vaginal and rectal colonization with type III GBS and only those negative were offered enrollment

Participant milestones

Participant milestones
Measure	GBS III-TT Vaccine The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).	Td Vaccine The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
Overall Study STARTED	333	334
Overall Study COMPLETED	264	263
Overall Study NOT COMPLETED	69	71

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Prevention of GBS Colonization Via Immunity

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	GBS III-TT Vaccine n=333 Participants The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).	Td Vaccine n=334 Participants The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).	Total n=667 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	333 Participants n=5 Participants	334 Participants n=7 Participants	667 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	26.2 years STANDARD_DEVIATION 5.58 • n=5 Participants	26.1 years STANDARD_DEVIATION 5.68 • n=7 Participants	26.2 years STANDARD_DEVIATION 5.63 • n=5 Participants
Sex: Female, Male Female	333 Participants n=5 Participants	334 Participants n=7 Participants	667 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	333 participants n=5 Participants	334 participants n=7 Participants	667 participants n=5 Participants

PRIMARY outcome

Timeframe: Time from vaccination to acquisition of vaginal type III GBS, up to 18 months post-vaccination.

Population: All enrolled participants with at least one post-enrollment efficacy assessment were included in the intention to treat (ITT) Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.

Time to first acquisition of vaginal type III GBS was calculated as time from vaccination to the mid-point of the interval of ascertainment, censored by either the end of the follow-up period, or the first of 2 or more consecutive missed visits. Vaginal type III GBS status at missed visits prior to censoring was imputed from the subsequent visit.

Outcome measures

Outcome measures
Measure	GBS III-TT Vaccine n=325 Participants The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).	Td Vaccine n=325 Participants The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
The Time to First Vaginal Swab That is Type III GBS Culture Positive, With All Previous Cultures Negative for Type III GBS, Not Just the Immediately Preceding Culture. Month 0 to 2 at risk	325 Participants	325 Participants
The Time to First Vaginal Swab That is Type III GBS Culture Positive, With All Previous Cultures Negative for Type III GBS, Not Just the Immediately Preceding Culture. Month 0 to 2 with GBS	20 Participants	15 Participants
The Time to First Vaginal Swab That is Type III GBS Culture Positive, With All Previous Cultures Negative for Type III GBS, Not Just the Immediately Preceding Culture. Month 0 to 2 censored	18 Participants	15 Participants
The Time to First Vaginal Swab That is Type III GBS Culture Positive, With All Previous Cultures Negative for Type III GBS, Not Just the Immediately Preceding Culture. Month 2 to 4 at risk	287 Participants	295 Participants
The Time to First Vaginal Swab That is Type III GBS Culture Positive, With All Previous Cultures Negative for Type III GBS, Not Just the Immediately Preceding Culture. Month 2 to 4 with GBS	5 Participants	6 Participants
The Time to First Vaginal Swab That is Type III GBS Culture Positive, With All Previous Cultures Negative for Type III GBS, Not Just the Immediately Preceding Culture. Month 2 to 4 censored	13 Participants	7 Participants
The Time to First Vaginal Swab That is Type III GBS Culture Positive, With All Previous Cultures Negative for Type III GBS, Not Just the Immediately Preceding Culture. Month 4 to 6 at risk	269 Participants	282 Participants
The Time to First Vaginal Swab That is Type III GBS Culture Positive, With All Previous Cultures Negative for Type III GBS, Not Just the Immediately Preceding Culture. Month 4 to 6 with GBS	1 Participants	7 Participants
The Time to First Vaginal Swab That is Type III GBS Culture Positive, With All Previous Cultures Negative for Type III GBS, Not Just the Immediately Preceding Culture. Month 4 to 6 censored	8 Participants	7 Participants
The Time to First Vaginal Swab That is Type III GBS Culture Positive, With All Previous Cultures Negative for Type III GBS, Not Just the Immediately Preceding Culture. Month 6 to 8 at risk	260 Participants	268 Participants
The Time to First Vaginal Swab That is Type III GBS Culture Positive, With All Previous Cultures Negative for Type III GBS, Not Just the Immediately Preceding Culture. Month 6 to 8 with GBS	3 Participants	8 Participants
The Time to First Vaginal Swab That is Type III GBS Culture Positive, With All Previous Cultures Negative for Type III GBS, Not Just the Immediately Preceding Culture. Month 6 to 8 censored	10 Participants	9 Participants
The Time to First Vaginal Swab That is Type III GBS Culture Positive, With All Previous Cultures Negative for Type III GBS, Not Just the Immediately Preceding Culture. Month 8 to 10 at risk	247 Participants	251 Participants
The Time to First Vaginal Swab That is Type III GBS Culture Positive, With All Previous Cultures Negative for Type III GBS, Not Just the Immediately Preceding Culture. Month 8 to 10 with GBS	0 Participants	2 Participants
The Time to First Vaginal Swab That is Type III GBS Culture Positive, With All Previous Cultures Negative for Type III GBS, Not Just the Immediately Preceding Culture. Month 8 to 10 censored	8 Participants	6 Participants
The Time to First Vaginal Swab That is Type III GBS Culture Positive, With All Previous Cultures Negative for Type III GBS, Not Just the Immediately Preceding Culture. Month 10 to 12 at risk	239 Participants	243 Participants
The Time to First Vaginal Swab That is Type III GBS Culture Positive, With All Previous Cultures Negative for Type III GBS, Not Just the Immediately Preceding Culture. Month 10 to 12 with GBS	0 Participants	7 Participants
The Time to First Vaginal Swab That is Type III GBS Culture Positive, With All Previous Cultures Negative for Type III GBS, Not Just the Immediately Preceding Culture. Month 10 to 12 censored	4 Participants	12 Participants
The Time to First Vaginal Swab That is Type III GBS Culture Positive, With All Previous Cultures Negative for Type III GBS, Not Just the Immediately Preceding Culture. Month 12 to 14 at risk	235 Participants	224 Participants
The Time to First Vaginal Swab That is Type III GBS Culture Positive, With All Previous Cultures Negative for Type III GBS, Not Just the Immediately Preceding Culture. Month 12 to 14 with GBS	2 Participants	3 Participants
The Time to First Vaginal Swab That is Type III GBS Culture Positive, With All Previous Cultures Negative for Type III GBS, Not Just the Immediately Preceding Culture. Month 12 to 14 censored	7 Participants	3 Participants
The Time to First Vaginal Swab That is Type III GBS Culture Positive, With All Previous Cultures Negative for Type III GBS, Not Just the Immediately Preceding Culture. Month 14 to 16 at risk	226 Participants	218 Participants
The Time to First Vaginal Swab That is Type III GBS Culture Positive, With All Previous Cultures Negative for Type III GBS, Not Just the Immediately Preceding Culture. Month 14 to 16 with GBS	2 Participants	3 Participants
The Time to First Vaginal Swab That is Type III GBS Culture Positive, With All Previous Cultures Negative for Type III GBS, Not Just the Immediately Preceding Culture. Month 14 to 16 censored	4 Participants	3 Participants
The Time to First Vaginal Swab That is Type III GBS Culture Positive, With All Previous Cultures Negative for Type III GBS, Not Just the Immediately Preceding Culture. Month 16 to 18 at risk	220 Participants	212 Participants
The Time to First Vaginal Swab That is Type III GBS Culture Positive, With All Previous Cultures Negative for Type III GBS, Not Just the Immediately Preceding Culture. Month 16 to 18 with GBS	1 Participants	2 Participants
The Time to First Vaginal Swab That is Type III GBS Culture Positive, With All Previous Cultures Negative for Type III GBS, Not Just the Immediately Preceding Culture. Month 16 to 18 censored	185 Participants	168 Participants

SECONDARY outcome

Timeframe: Prior to and at 1, 2, 4, 6, 8, 10, 12, 14, 16, and 18 months following vaccination.

Population: All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.

The GMC was calculated from IgG antibody to type III GBS assay results on serum specimens obtained at clinic visits during the 18 month post-vaccination follow-up period. Results at missed visits prior to loss to follow-up/final visit were not imputed.

Outcome measures

Outcome measures
Measure	GBS III-TT Vaccine n=325 Participants The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).	Td Vaccine n=325 Participants The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
Geometric Mean Concentration (GMC) of Serum Immunoglobulin G (IgG) Antibody Levels to Type III GBS Post-Vaccination. Month 0	0.29 µg/ml Interval 0.25 to 0.35	0.31 µg/ml Interval 0.26 to 0.37
Geometric Mean Concentration (GMC) of Serum Immunoglobulin G (IgG) Antibody Levels to Type III GBS Post-Vaccination. Month 1	12.35 µg/ml Interval 9.6 to 15.9	0.29 µg/ml Interval 0.24 to 0.35
Geometric Mean Concentration (GMC) of Serum Immunoglobulin G (IgG) Antibody Levels to Type III GBS Post-Vaccination. Month 2	12.55 µg/ml Interval 9.95 to 15.81	0.30 µg/ml Interval 0.25 to 0.35
Geometric Mean Concentration (GMC) of Serum Immunoglobulin G (IgG) Antibody Levels to Type III GBS Post-Vaccination. Month 4	9.58 µg/ml Interval 7.67 to 11.97	0.29 µg/ml Interval 0.24 to 0.34
Geometric Mean Concentration (GMC) of Serum Immunoglobulin G (IgG) Antibody Levels to Type III GBS Post-Vaccination. Month 6	7.26 µg/ml Interval 5.84 to 9.03	0.29 µg/ml Interval 0.24 to 0.34
Geometric Mean Concentration (GMC) of Serum Immunoglobulin G (IgG) Antibody Levels to Type III GBS Post-Vaccination. Month 8	6.63 µg/ml Interval 5.32 to 8.27	0.26 µg/ml Interval 0.22 to 0.32
Geometric Mean Concentration (GMC) of Serum Immunoglobulin G (IgG) Antibody Levels to Type III GBS Post-Vaccination. Month 10	5.80 µg/ml Interval 4.64 to 7.24	0.28 µg/ml Interval 0.23 to 0.33
Geometric Mean Concentration (GMC) of Serum Immunoglobulin G (IgG) Antibody Levels to Type III GBS Post-Vaccination. Month 12	5.16 µg/ml Interval 4.14 to 6.43	0.27 µg/ml Interval 0.22 to 0.32
Geometric Mean Concentration (GMC) of Serum Immunoglobulin G (IgG) Antibody Levels to Type III GBS Post-Vaccination. Month 14	4.80 µg/ml Interval 3.84 to 6.0	0.26 µg/ml Interval 0.22 to 0.32
Geometric Mean Concentration (GMC) of Serum Immunoglobulin G (IgG) Antibody Levels to Type III GBS Post-Vaccination. Month 16	4.57 µg/ml Interval 3.67 to 5.69	0.28 µg/ml Interval 0.23 to 0.34
Geometric Mean Concentration (GMC) of Serum Immunoglobulin G (IgG) Antibody Levels to Type III GBS Post-Vaccination. Month 18	3.99 µg/ml Interval 3.22 to 4.94	0.27 µg/ml Interval 0.22 to 0.33

SECONDARY outcome

Timeframe: Safety surveillance during the 1st 7 days.

Population: The Safety Analysis Cohort is comprised of all vaccinated women, categorized according to the product received, regardless of their randomized assignment. Due to vaccination errors, the number of participants in the Td group for the Safety Analysis Cohort (n=337) exceeds the number randomized to this group (n=334).

Participants maintained a diary card to report the occurrence of solicited local and systemic symptoms for 7 days after vaccination. Participants are counted if they indicated experiencing the symptom at any severity during the reporting period.

Outcome measures

Outcome measures
Measure	GBS III-TT Vaccine n=326 Participants The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).	Td Vaccine n=337 Participants The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
Number of Participants With Any Solicited Local and Systemic Symptoms. General Arm Pain	175 Participants	223 Participants
Number of Participants With Any Solicited Local and Systemic Symptoms. Local Redness	27 Participants	40 Participants
Number of Participants With Any Solicited Local and Systemic Symptoms. Local Swelling	23 Participants	52 Participants
Number of Participants With Any Solicited Local and Systemic Symptoms. Local Tenderness at Injection Site	234 Participants	276 Participants
Number of Participants With Any Solicited Local and Systemic Symptoms. Any Solicited Local Symptom	251 Participants	294 Participants
Number of Participants With Any Solicited Local and Systemic Symptoms. Chills	30 Participants	33 Participants
Number of Participants With Any Solicited Local and Systemic Symptoms. Headache	130 Participants	118 Participants
Number of Participants With Any Solicited Local and Systemic Symptoms. Elevated Oral Temperature (>37.4 degrees Celsius)	33 Participants	32 Participants
Number of Participants With Any Solicited Local and Systemic Symptoms. Malaise (Decreased energy)	103 Participants	111 Participants
Number of Participants With Any Solicited Local and Systemic Symptoms. Myalgia (General muscle aches)	91 Participants	112 Participants
Number of Participants With Any Solicited Local and Systemic Symptoms. Nausea	55 Participants	61 Participants
Number of Participants With Any Solicited Local and Systemic Symptoms. Any Solicited Systemic Symptom	208 Participants	206 Participants
Number of Participants With Any Solicited Local and Systemic Symptoms. Any Solicited Symptom	282 Participants	307 Participants

SECONDARY outcome

Timeframe: Prior to and at 1, 2, 4, 6, 8, 10, 12, 14, 16, and 18 months following vaccination.

Population: All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.

Fold-rises compare the IgG antibody level at post-vaccination to that obtained just prior to vaccination, for each visit during the 18-month follow-up period. Assay results at missed visits prior to loss to follow-up/final visit were not imputed.

Outcome measures

Outcome measures
Measure	GBS III-TT Vaccine n=325 Participants The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).	Td Vaccine n=325 Participants The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
Mean Fold-Rise in Serum IgG Antibody Levels to Type III GBS Post-Vaccination Month 16	15.89 Ratio Interval 13.7 to 18.42	0.90 Ratio Interval 0.85 to 0.95
Mean Fold-Rise in Serum IgG Antibody Levels to Type III GBS Post-Vaccination Month 0	1.00 Ratio Interval 1.0 to 1.0	1.00 Ratio Interval 1.0 to 1.0
Mean Fold-Rise in Serum IgG Antibody Levels to Type III GBS Post-Vaccination Month 1	41.29 Ratio Interval 34.7 to 49.12	0.99 Ratio Interval 0.95 to 1.03
Mean Fold-Rise in Serum IgG Antibody Levels to Type III GBS Post-Vaccination Month 2	41.06 Ratio Interval 35.27 to 47.8	0.98 Ratio Interval 0.94 to 1.02
Mean Fold-Rise in Serum IgG Antibody Levels to Type III GBS Post-Vaccination Month 4	31.64 Ratio Interval 27.35 to 36.6	0.93 Ratio Interval 0.9 to 0.97
Mean Fold-Rise in Serum IgG Antibody Levels to Type III GBS Post-Vaccination Month 6	25.56 Ratio Interval 22.07 to 29.59	0.92 Ratio Interval 0.88 to 0.97
Mean Fold-Rise in Serum IgG Antibody Levels to Type III GBS Post-Vaccination Month 8	21.92 Ratio Interval 18.95 to 25.36	0.89 Ratio Interval 0.84 to 0.94
Mean Fold-Rise in Serum IgG Antibody Levels to Type III GBS Post-Vaccination Month 10	19.78 Ratio Interval 17.08 to 22.91	0.91 Ratio Interval 0.87 to 0.96
Mean Fold-Rise in Serum IgG Antibody Levels to Type III GBS Post-Vaccination Month 12	17.71 Ratio Interval 15.3 to 20.5	0.91 Ratio Interval 0.86 to 0.96
Mean Fold-Rise in Serum IgG Antibody Levels to Type III GBS Post-Vaccination Month 14	16.76 Ratio Interval 14.41 to 19.49	0.92 Ratio Interval 0.87 to 0.98
Mean Fold-Rise in Serum IgG Antibody Levels to Type III GBS Post-Vaccination Month 18	14.26 Ratio Interval 12.33 to 16.48	0.92 Ratio Interval 0.87 to 0.97

SECONDARY outcome

Timeframe: Prior to and 1 month following vaccination

Population: All enrolled participants with blood collected at both time points were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.

Blood samples were collected from participants prior to vaccination and at 1 month post vaccination, and serum was assayed with an ELISA to measure IgG antibody levels to Type III GBS. The lower detection limit for the assay was 0.08 micrograms/milliliter (µg/mL), and antibody levels below this limit were recorded as 0.04 µg/mL by the laboratory. Fold rises compare IgG antibody levels at the post-vaccination visit to that obtained just prior to vaccination. Participants are considered a responder if the antibody increase was four-fold or greater.

Outcome measures

Outcome measures
Measure	GBS III-TT Vaccine n=304 Participants The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).	Td Vaccine n=303 Participants The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
Number of Participants With a Four-Fold or Greater Rise in Serum IgG Antibody to Type III GBS at Month 1 Post-Vaccination	277 participants	1 participants

SECONDARY outcome

Timeframe: Prior to and 2 months following vaccination

Population: All enrolled participants with blood collected at both time points were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.

Blood samples were collected from participants prior to vaccination and at 2 months post vaccination, and serum was assayed with an ELISA to measure IgG antibody levels to Type III GBS. The lower detection limit for the assay was 0.08 micrograms/milliliter (µg/mL), and antibody levels below this limit were recorded as 0.04 µg/mL by the laboratory. Fold rises compare IgG antibody levels at the post-vaccination visit to that obtained just prior to vaccination. Participants are considered a responder if the antibody increase was four-fold or greater.

Outcome measures

Outcome measures
Measure	GBS III-TT Vaccine n=301 Participants The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).	Td Vaccine n=310 Participants The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
Number of Participants With a Four-Fold or Greater Rise in Serum IgG Antibody to Type III GBS at Month 2 Post-Vaccination	286 participants	1 participants

SECONDARY outcome

Timeframe: Prior to and 4 months following vaccination

Population: All enrolled participants with blood collected at both time points were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.

Blood samples were collected from participants prior to vaccination and at 4 months post vaccination, and serum was assayed with an ELISA to measure IgG antibody levels to Type III GBS. The lower detection limit for the assay was 0.08 micrograms/milliliter (µg/mL), and antibody levels below this limit were recorded as 0.04 µg/mL by the laboratory. Fold rises compare IgG antibody levels at the post-vaccination visit to that obtained just prior to vaccination. Participants are considered a responder if the antibody increase was four-fold or greater.

Outcome measures

Outcome measures
Measure	GBS III-TT Vaccine n=289 Participants The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).	Td Vaccine n=298 Participants The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
Number of Participants With a Four-Fold or Greater Rise in Serum IgG Antibody to Type III GBS at Month 4 Post-Vaccination	272 participants	2 participants

SECONDARY outcome

Timeframe: Prior to and 6 months following vaccination

Population: All enrolled participants with blood collected at both time points were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.

Blood samples were collected from participants prior to vaccination and at 6 months post vaccination, and serum was assayed with an ELISA to measure IgG antibody levels to Type III GBS. The lower detection limit for the assay was 0.08 micrograms/milliliter (µg/mL), and antibody levels below this limit were recorded as 0.04 µg/mL by the laboratory. Fold rises compare IgG antibody levels at the post-vaccination visit to that obtained just prior to vaccination. Participants are considered a responder if the antibody increase was four-fold or greater.

Outcome measures

Outcome measures
Measure	GBS III-TT Vaccine n=279 Participants The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).	Td Vaccine n=287 Participants The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
Number of Participants With a Four-Fold or Greater Rise in Serum IgG Antibody to Type III GBS at Month 6 Post-Vaccination	264 participants	1 participants

SECONDARY outcome

Timeframe: Prior to and 8 month following vaccination

Population: All enrolled participants with blood collected at both time points were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.

Blood samples were collected from participants prior to vaccination and at 8 month post vaccination, and serum was assayed with an ELISA to measure IgG antibody levels to Type III GBS. The lower detection limit for the assay was 0.08 micrograms/milliliter (µg/mL), and antibody levels below this limit were recorded as 0.04 µg/mL by the laboratory. Fold rises compare IgG antibody levels at the post-vaccination visit to that obtained just prior to vaccination. Participants are considered a responder if the antibody increase was four-fold or greater.

Outcome measures

Outcome measures
Measure	GBS III-TT Vaccine n=275 Participants The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).	Td Vaccine n=278 Participants The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
Number of Participants With a Four-Fold or Greater Rise in Serum IgG Antibody to Type III GBS at Month 8 Post-Vaccination	256 participants	1 participants

SECONDARY outcome

Timeframe: Prior to and 10 months following vaccination

Population: All enrolled participants with blood collected at both time points were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.

Blood samples were collected from participants prior to vaccination and at 10 months post vaccination, and serum was assayed with an ELISA to measure IgG antibody levels to Type III GBS. The lower detection limit for the assay was 0.08 micrograms/milliliter (µg/mL), and antibody levels below this limit were recorded as 0.04 µg/mL by the laboratory. Fold rises compare IgG antibody levels at the post-vaccination visit to that obtained just prior to vaccination. Participants are considered a responder if the antibody increase was four-fold or greater.

Outcome measures

Outcome measures
Measure	GBS III-TT Vaccine n=271 Participants The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).	Td Vaccine n=262 Participants The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
Number of Participants With a Four-Fold or Greater Rise in Serum IgG Antibody to Type III GBS at Month 10 Post-Vaccination	250 participants	1 participants

SECONDARY outcome

Timeframe: Prior to and 12 months following vaccination

Population: All enrolled participants with blood collected at both time points were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.

Blood samples were collected from participants prior to vaccination and at 12 months post vaccination, and serum was assayed with an ELISA to measure IgG antibody levels to Type III GBS. The lower detection limit for the assay was 0.08 micrograms/milliliter (µg/mL), and antibody levels below this limit were recorded as 0.04 µg/mL by the laboratory. Fold rises compare IgG antibody levels at the post-vaccination visit to that obtained just prior to vaccination. Participants are considered a responder if the antibody increase was four-fold or greater.

Outcome measures

Outcome measures
Measure	GBS III-TT Vaccine n=271 Participants The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).	Td Vaccine n=274 Participants The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
Number of Participants With a Four-Fold or Greater Rise in Serum IgG Antibody to Type III GBS at Month 12 Post-Vaccination	245 participants	2 participants

SECONDARY outcome

Timeframe: Prior to and 14 months following vaccination

Population: All enrolled participants with blood collected at both time points were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.

Blood samples were collected from participants prior to vaccination and at 14 months post vaccination, and serum was assayed with an ELISA to measure IgG antibody levels to Type III GBS. The lower detection limit for the assay was 0.08 micrograms/milliliter (µg/mL), and antibody levels below this limit were recorded as 0.04 µg/mL by the laboratory. Fold rises compare IgG antibody levels at the post-vaccination visit to that obtained just prior to vaccination. Participants are considered a responder if the antibody increase was four-fold or greater.

Outcome measures

Outcome measures
Measure	GBS III-TT Vaccine n=258 Participants The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).	Td Vaccine n=261 Participants The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
Number of Participants With a Four-Fold or Greater Rise in Serum IgG Antibody to Type III GBS at Month 14 Post-Vaccination	231 participants	3 participants

SECONDARY outcome

Timeframe: Prior to and 16 months following vaccination

Population: All enrolled participants with blood collected at both time points were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.

Blood samples were collected from participants prior to vaccination and at 16 months post vaccination, and serum was assayed with an ELISA to measure IgG antibody levels to Type III GBS. The lower detection limit for the assay was 0.08 micrograms/milliliter (µg/mL), and antibody levels below this limit were recorded as 0.04 µg/mL by the laboratory. Fold rises compare IgG antibody levels at the post-vaccination visit to that obtained just prior to vaccination. Participants are considered a responder if the antibody increase was four-fold or greater.

Outcome measures

Outcome measures
Measure	GBS III-TT Vaccine n=256 Participants The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).	Td Vaccine n=260 Participants The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
Number of Participants With a Four-Fold or Greater Rise in Serum IgG Antibody to Type III GBS at Month 16 Post-Vaccination	228 participants	2 participants

SECONDARY outcome

Timeframe: Prior to and 18 months following vaccination

Population: All enrolled participants with blood collected at both time points were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.

Blood samples were collected from participants prior to vaccination and at 18 months post vaccination, and serum was assayed with an ELISA to measure IgG antibody levels to Type III GBS. The lower detection limit for the assay was 0.08 micrograms/milliliter (µg/mL), and antibody levels below this limit were recorded as 0.04 µg/mL by the laboratory. Fold rises compare IgG antibody levels at the post-vaccination visit to that obtained just prior to vaccination. Participants are considered a responder if the antibody increase was four-fold or greater.

Outcome measures

Outcome measures
Measure	GBS III-TT Vaccine n=264 Participants The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).	Td Vaccine n=261 Participants The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
Number of Participants With a Four-Fold or Greater Rise in Serum IgG Antibody to Type III GBS at Month 18 Post-Vaccination	229 participants	1 participants

SECONDARY outcome

Timeframe: Month 0 prior to vaccination

Population: All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.

Blood samples were collected from participants at each scheduled clinic visit beginning with Month 0 prior to vaccination, and serum was assayed with an ELISA to measure IgG antibody levels to Type III GBS. The threshold for being considered seropositive was 5 µg/mL.

Outcome measures

Outcome measures
Measure	GBS III-TT Vaccine n=325 Participants The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).	Td Vaccine n=325 Participants The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
Number of Participants With a Serum IgG Antibody to Type III GBS Post-Vaccination of 5 µg/mL or Greater at Month 0	25 participants	18 participants

SECONDARY outcome

Timeframe: Month 1

Population: All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.

Blood samples were collected from participants at each scheduled clinic visit and serum was assayed with an ELISA to measure IgG antibody levels to Type III GBS. The threshold for being considered seropositive was 5 µg/mL.

Outcome measures

Outcome measures
Measure	GBS III-TT Vaccine n=304 Participants The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).	Td Vaccine n=303 Participants The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
Number of Participants With a Serum IgG Antibody to Type III GBS Post-Vaccination of 5 µg/mL or Greater at Month 1 Post Vaccination	192 participants	12 participants

SECONDARY outcome

Timeframe: Month 2

Population: All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.

Blood samples were collected from participants at each scheduled clinic visit and serum was assayed with an ELISA to measure IgG antibody levels to Type III GBS. The threshold for being considered seropositive was 5 µg/mL.

Outcome measures

Outcome measures
Measure	GBS III-TT Vaccine n=301 Participants The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).	Td Vaccine n=310 Participants The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
Number of Participants With a Serum IgG Antibody to Type III GBS Post-Vaccination of 5 µg/mL or Greater at Month 2 Post Vaccination	186 participants	13 participants

SECONDARY outcome

Timeframe: Month 4

Population: All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.

Blood samples were collected from participants at each scheduled clinic visit, and serum was assayed with an ELISA to measure IgG antibody levels to Type III GBS. The threshold for being considered seropositive was 5 µg/mL.

Outcome measures

Outcome measures
Measure	GBS III-TT Vaccine n=289 Participants The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).	Td Vaccine n=298 Participants The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
Number of Participants With a Serum IgG Antibody to Type III GBS Post-Vaccination of 5 µg/mL or Greater at Month 4 Post Vaccination	174 participants	12 participants

SECONDARY outcome

Timeframe: Month 6

Population: All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.

Blood samples were collected from participants at each scheduled clinic visit, and serum was assayed with an ELISA to measure IgG antibody levels to Type III GBS. The threshold for being considered seropositive was 5 µg/mL.

Outcome measures

Outcome measures
Measure	GBS III-TT Vaccine n=279 Participants The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).	Td Vaccine n=287 Participants The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
Number of Participants With a Serum IgG Antibody to Type III GBS Post-Vaccination of 5 µg/mL or Greater at Month 6 Post Vaccination	155 participants	11 participants

SECONDARY outcome

Timeframe: Month 8

Population: All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.

Blood samples were collected from participants at each scheduled clinic visit, and serum was assayed with an ELISA to measure IgG antibody levels to Type III GBS. The threshold for being considered seropositive was 5 µg/mL.

Outcome measures

Outcome measures
Measure	GBS III-TT Vaccine n=275 Participants The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).	Td Vaccine n=278 Participants The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
Number of Participants With a Serum IgG Antibody to Type III GBS Post-Vaccination of 5 µg/mL or Greater at Month 8 Post Vaccination	151 participants	9 participants

SECONDARY outcome

Timeframe: Month 10

Population: All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.

Blood samples were collected from participants at each scheduled clinic visit, and serum was assayed with an ELISA to measure IgG antibody levels to Type III GBS. The threshold for being considered seropositive was 5 µg/mL.

Outcome measures

Outcome measures
Measure	GBS III-TT Vaccine n=271 Participants The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).	Td Vaccine n=262 Participants The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
Number of Participants With a Serum IgG Antibody to Type III GBS Post-Vaccination of 5 µg/mL or Greater at Month 10 Post Vaccination	137 participants	10 participants

SECONDARY outcome

Timeframe: Month 12

Population: All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.

Blood samples were collected from participants at each scheduled clinic visit, and serum was assayed with an ELISA to measure IgG antibody levels to Type III GBS. The threshold for being considered seropositive was 5 µg/mL.

Outcome measures

Outcome measures
Measure	GBS III-TT Vaccine n=271 Participants The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).	Td Vaccine n=274 Participants The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
Number of Participants With a Serum IgG Antibody to Type III GBS Post-Vaccination of 5 µg/mL or Greater at Month 12 Post Vaccination	136 participants	10 participants

SECONDARY outcome

Timeframe: Month 14

Population: All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.

Blood samples were collected from participants at each scheduled clinic visit, and serum was assayed with an ELISA to measure IgG antibody levels to Type III GBS. The threshold for being considered seropositive was 5 µg/mL.

Outcome measures

Outcome measures
Measure	GBS III-TT Vaccine n=258 Participants The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).	Td Vaccine n=261 Participants The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
Number of Participants With a Serum IgG Antibody to Type III GBS Post-Vaccination of 5 µg/mL or Greater at Month 14 Post Vaccination	126 participants	9 participants

SECONDARY outcome

Timeframe: Month 16

Population: All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.

Blood samples were collected from participants at each scheduled clinic visit, and serum was assayed with an ELISA to measure IgG antibody levels to Type III GBS. The threshold for being considered seropositive was 5 µg/mL.

Outcome measures

Outcome measures
Measure	GBS III-TT Vaccine n=256 Participants The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).	Td Vaccine n=260 Participants The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
Number of Participants With a Serum IgG Antibody to Type III GBS Post-Vaccination of 5 µg/mL or Greater at Month 16 Post Vaccination	122 participants	8 participants

SECONDARY outcome

Timeframe: Month 18

Population: All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.

Blood samples were collected from participants at each scheduled clinic visit, and serum was assayed with an ELISA to measure IgG antibody levels to Type III GBS. The threshold for being considered seropositive was 5 µg/mL.

Outcome measures

Outcome measures
Measure	GBS III-TT Vaccine n=264 Participants The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).	Td Vaccine n=261 Participants The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
Number of Participants With a Serum IgG Antibody to Type III GBS Post-Vaccination of 5 µg/mL or Greater at Month 18 Post Vaccination	117 participants	9 participants

SECONDARY outcome

Timeframe: Every 2 months from time of vaccination up to 18 months post-vaccination.

Population: All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.

Number of participants who were vaginal type III GBS negative was calculated throughout the the eighteen month post-vaccination follow-up period. Status at missed visits prior to loss to follow-up /final visit was imputed from the subsequent visit.

Outcome measures

Outcome measures
Measure	GBS III-TT Vaccine n=325 Participants The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).	Td Vaccine n=325 Participants The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
Number of Participants Whose Vaginal Cultures Are Type III GBS Culture Negative Throughout the Study. Always Vaginal Negative - False	39 Participants	54 Participants
Number of Participants Whose Vaginal Cultures Are Type III GBS Culture Negative Throughout the Study. Always Vaginal Negative - True	286 Participants	271 Participants

SECONDARY outcome

Timeframe: Every 2 months from time of vaccination up to 18 months post-vaccination.

Population: All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.

Number of participants whose vaginal swabs were type III GBS culture positive was calculated using data from the eighteen month post-vaccination follow-up period. Status at missed visits prior to loss to follow-up/final visit was imputed from the previous visit.

Outcome measures

Outcome measures
Measure	GBS III-TT Vaccine n=325 Participants The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).	Td Vaccine n=325 Participants The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
Number of Participants Whose Vaginal Cultures Were Type III GBS Culture Positive. Month 1 - Missing	5 Participants	2 Participants
Number of Participants Whose Vaginal Cultures Were Type III GBS Culture Positive. Month 1 - Negative	313 Participants	314 Participants
Number of Participants Whose Vaginal Cultures Were Type III GBS Culture Positive. Month 1 - Positive	7 Participants	9 Participants
Number of Participants Whose Vaginal Cultures Were Type III GBS Culture Positive. Month 2 - Missing	8 Participants	7 Participants
Number of Participants Whose Vaginal Cultures Were Type III GBS Culture Positive. Month 2 - Negative	303 Participants	310 Participants
Number of Participants Whose Vaginal Cultures Were Type III GBS Culture Positive. Month 2 - Positive	14 Participants	8 Participants
Number of Participants Whose Vaginal Cultures Were Type III GBS Culture Positive. Month 4 - Missing	24 Participants	15 Participants
Number of Participants Whose Vaginal Cultures Were Type III GBS Culture Positive. Month 4 - Negative	292 Participants	301 Participants
Number of Participants Whose Vaginal Cultures Were Type III GBS Culture Positive. Month 4 - Positive	9 Participants	9 Participants
Number of Participants Whose Vaginal Cultures Were Type III GBS Culture Positive. Month 6 - Missing	25 Participants	22 Participants
Number of Participants Whose Vaginal Cultures Were Type III GBS Culture Positive. Month 6 - Negative	293 Participants	291 Participants
Number of Participants Whose Vaginal Cultures Were Type III GBS Culture Positive. Month 6 - Positive	7 Participants	12 Participants
Number of Participants Whose Vaginal Cultures Were Type III GBS Culture Positive. Month 8 - Missing	34 Participants	29 Participants
Number of Participants Whose Vaginal Cultures Were Type III GBS Culture Positive. Month 8 - Negative	282 Participants	279 Participants
Number of Participants Whose Vaginal Cultures Were Type III GBS Culture Positive. Month 8 - Positive	9 Participants	17 Participants
Number of Participants Whose Vaginal Cultures Were Type III GBS Culture Positive. Month 10 - Missing	41 Participants	38 Participants
Number of Participants Whose Vaginal Cultures Were Type III GBS Culture Positive. Month 10 - Negative	279 Participants	273 Participants
Number of Participants Whose Vaginal Cultures Were Type III GBS Culture Positive. Month 10 - Positive	5 Participants	14 Participants
Number of Participants Whose Vaginal Cultures Were Type III GBS Culture Positive. Month 12 - Missing	48 Participants	42 Participants
Number of Participants Whose Vaginal Cultures Were Type III GBS Culture Positive. Month 12 - Negative	272 Participants	266 Participants
Number of Participants Whose Vaginal Cultures Were Type III GBS Culture Positive. Month 12 - Positive	5 Participants	17 Participants
Number of Participants Whose Vaginal Cultures Were Type III GBS Culture Positive. Month 14 - Missing	52 Participants	51 Participants
Number of Participants Whose Vaginal Cultures Were Type III GBS Culture Positive. Month 14 - Negative	268 Participants	259 Participants
Number of Participants Whose Vaginal Cultures Were Type III GBS Culture Positive. Month 14 - Positive	5 Participants	15 Participants
Number of Participants Whose Vaginal Cultures Were Type III GBS Culture Positive. Month 16 - Missing	58 Participants	56 Participants
Number of Participants Whose Vaginal Cultures Were Type III GBS Culture Positive. Month 16 - Negative	260 Participants	257 Participants
Number of Participants Whose Vaginal Cultures Were Type III GBS Culture Positive. Month 16 - Positive	7 Participants	12 Participants
Number of Participants Whose Vaginal Cultures Were Type III GBS Culture Positive. Month 18 - Missing	61 Participants	62 Participants
Number of Participants Whose Vaginal Cultures Were Type III GBS Culture Positive. Month 18 - Negative	256 Participants	255 Participants
Number of Participants Whose Vaginal Cultures Were Type III GBS Culture Positive. Month 18 - Positive	7 Participants	8 Participants
Number of Participants Whose Vaginal Cultures Were Type III GBS Culture Positive. All Clinic Visits - Missing	356 Participants	324 Participants
Number of Participants Whose Vaginal Cultures Were Type III GBS Culture Positive. All Clinic Visits - Negative	3138 Participants	3126 Participants
Number of Participants Whose Vaginal Cultures Were Type III GBS Culture Positive. All Clinic Visits - Positive	80 Participants	125 Participants

SECONDARY outcome

Timeframe: Every 2 months from time of vaccination up to 18 months post-vaccination.

Population: All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.

Number of vaginal GBS III culture positive for 3+ consecutive visits was calculated from the post-vaccination visits over the 18 month follow-up. Status at missed visits prior to loss to follow-up/final visit was imputed from the subsequent visit.

Outcome measures

Outcome measures
Measure	GBS III-TT Vaccine n=325 Participants The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).	Td Vaccine n=325 Participants The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
Number of Participants Whose Vaginal Cultures Were Persistently Type III GBS Culture Positive for Three or More Consecutive Visits Persistent Colonization - False	318 Participants	312 Participants
Number of Participants Whose Vaginal Cultures Were Persistently Type III GBS Culture Positive for Three or More Consecutive Visits Persistent Colonization - True	7 Participants	13 Participants

SECONDARY outcome

Timeframe: Month 0

Population: All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.

The density of type III GBS is an ordinal response with six Density Levels: negative (lowest density, Score 0); broth only (Score 1); 1+ (Score 2); 2+ (Score 3); 3+ (Score 4); and 4+ (highest density, Score 5). The number of swabs with each score was tabulated from swabs collected at Month 0 prior to vaccination.

Outcome measures

Outcome measures
Measure	GBS III-TT Vaccine n=325 Participants The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).	Td Vaccine n=325 Participants The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
The Density of Type III GBS Cultured From Vaginal Swabs at Month 0 Negative	321 Swabs	320 Swabs
The Density of Type III GBS Cultured From Vaginal Swabs at Month 0 Broth only	0 Swabs	1 Swabs
The Density of Type III GBS Cultured From Vaginal Swabs at Month 0 1+	0 Swabs	0 Swabs
The Density of Type III GBS Cultured From Vaginal Swabs at Month 0 2+	0 Swabs	0 Swabs
The Density of Type III GBS Cultured From Vaginal Swabs at Month 0 3+	0 Swabs	0 Swabs
The Density of Type III GBS Cultured From Vaginal Swabs at Month 0 4+	4 Swabs	4 Swabs

SECONDARY outcome

Timeframe: Month 1

Population: All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.

The density of type III GBS is an ordinal response with six Density Levels: negative (lowest density, Score 0); broth only (Score 1); 1+ (Score 2); 2+ (Score 3); 3+ (Score 4); and 4+ (highest density, Score 5). The number of swabs with each score was tabulated from swabs collected at Month 1. Density at missed visits prior to loss to follow-up/final visit was imputed from the subsequent visit.

Outcome measures

Outcome measures
Measure	GBS III-TT Vaccine n=323 Participants The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).	Td Vaccine n=320 Participants The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
The Density of Type III GBS Cultured From Vaginal Swabs at Month 1 Broth only	1 Swabs	1 Swabs
The Density of Type III GBS Cultured From Vaginal Swabs at Month 1 1+	0 Swabs	1 Swabs
The Density of Type III GBS Cultured From Vaginal Swabs at Month 1 2+	1 Swabs	1 Swabs
The Density of Type III GBS Cultured From Vaginal Swabs at Month 1 3+	2 Swabs	3 Swabs
The Density of Type III GBS Cultured From Vaginal Swabs at Month 1 4+	5 Swabs	1 Swabs
The Density of Type III GBS Cultured From Vaginal Swabs at Month 1 Negative	314 Swabs	313 Swabs

SECONDARY outcome

Timeframe: Month 2

Population: All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.

The density of type III GBS is an ordinal response with six Density Levels: negative (lowest density, Score 0); broth only (Score 1); 1+ (Score 2); 2+ (Score 3); 3+ (Score 4); and 4+ (highest density, Score 5). The number of swabs with each score was tabulated from swabs collected at Month 2. Density at missed visits prior to loss to follow-up/final visit was imputed from the subsequent visit.

Outcome measures

Outcome measures
Measure	GBS III-TT Vaccine n=318 Participants The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).	Td Vaccine n=317 Participants The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
The Density of Type III GBS Cultured From Vaginal Swabs at Month 2 Negative	310 Swabs	303 Swabs
The Density of Type III GBS Cultured From Vaginal Swabs at Month 2 Broth only	0 Swabs	1 Swabs
The Density of Type III GBS Cultured From Vaginal Swabs at Month 2 1+	0 Swabs	1 Swabs
The Density of Type III GBS Cultured From Vaginal Swabs at Month 2 2+	2 Swabs	1 Swabs
The Density of Type III GBS Cultured From Vaginal Swabs at Month 2 3+	1 Swabs	2 Swabs
The Density of Type III GBS Cultured From Vaginal Swabs at Month 2 4+	5 Swabs	9 Swabs

SECONDARY outcome

Timeframe: Month 4

Population: All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.

The density of type III GBS is an ordinal response with six Density Levels: negative (lowest density, Score 0); broth only (Score 1); 1+ (Score 2); 2+ (Score 3); 3+ (Score 4); and 4+ (highest density, Score 5). The number of swabs with each score was tabulated from swabs collected at Month 4. Density at missed visits prior to loss to follow-up/final visit was imputed from the subsequent visit.

Outcome measures

Outcome measures
Measure	GBS III-TT Vaccine n=310 Participants The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).	Td Vaccine n=301 Participants The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
The Density of Type III GBS Cultured From Vaginal Swabs at Month 4 Negative	301 Swabs	292 Swabs
The Density of Type III GBS Cultured From Vaginal Swabs at Month 4 Broth only	2 Swabs	0 Swabs
The Density of Type III GBS Cultured From Vaginal Swabs at Month 4 1+	1 Swabs	2 Swabs
The Density of Type III GBS Cultured From Vaginal Swabs at Month 4 2+	2 Swabs	0 Swabs
The Density of Type III GBS Cultured From Vaginal Swabs at Month 4 3+	1 Swabs	3 Swabs
The Density of Type III GBS Cultured From Vaginal Swabs at Month 4 4+	3 Swabs	4 Swabs

SECONDARY outcome

Timeframe: Month 6

Population: All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.

The density of type III GBS is an ordinal response with six Density Levels: negative (lowest density, Score 0); broth only (Score 1); 1+ (Score 2); 2+ (Score 3); 3+ (Score 4); and 4+ (highest density, Score 5). The number of swabs with each score was tabulated from swabs collected at Month 6. Density at missed visits prior to loss to follow-up/final visit was imputed from the subsequent visit.

Outcome measures

Outcome measures
Measure	GBS III-TT Vaccine n=303 Participants The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).	Td Vaccine n=300 Participants The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
The Density of Type III GBS Cultured From Vaginal Swabs at Month 6 Negative	291 Swabs	293 Swabs
The Density of Type III GBS Cultured From Vaginal Swabs at Month 6 Broth only	1 Swabs	2 Swabs
The Density of Type III GBS Cultured From Vaginal Swabs at Month 6 1+	0 Swabs	0 Swabs
The Density of Type III GBS Cultured From Vaginal Swabs at Month 6 2+	1 Swabs	0 Swabs
The Density of Type III GBS Cultured From Vaginal Swabs at Month 6 3+	2 Swabs	2 Swabs
The Density of Type III GBS Cultured From Vaginal Swabs at Month 6 4+	8 Swabs	3 Swabs

SECONDARY outcome

Timeframe: Month 8

Population: All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.

The density of type III GBS is an ordinal response with six Density Levels: negative (lowest density, Score 0); broth only (Score 1); 1+ (Score 2); 2+ (Score 3); 3+ (Score 4); and 4+ (highest density, Score 5). The number of swabs with each score was tabulated from swabs collected at Month 8. Density at missed visits prior to loss to follow-up/final visit was imputed from the subsequent visit.

Outcome measures

Outcome measures
Measure	GBS III-TT Vaccine n=296 Participants The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).	Td Vaccine n=291 Participants The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
The Density of Type III GBS Cultured From Vaginal Swabs at Month 8 Negative	279 Swabs	282 Swabs
The Density of Type III GBS Cultured From Vaginal Swabs at Month 8 Broth only	3 Swabs	1 Swabs
The Density of Type III GBS Cultured From Vaginal Swabs at Month 8 1+	0 Swabs	0 Swabs
The Density of Type III GBS Cultured From Vaginal Swabs at Month 8 2+	0 Swabs	2 Swabs
The Density of Type III GBS Cultured From Vaginal Swabs at Month 8 3+	1 Swabs	2 Swabs
The Density of Type III GBS Cultured From Vaginal Swabs at Month 8 4+	13 Swabs	4 Swabs

SECONDARY outcome

Timeframe: Month 10

Population: All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.

The density of type III GBS is an ordinal response with six Density Levels: negative (lowest density, Score 0); broth only (Score 1); 1+ (Score 2); 2+ (Score 3); 3+ (Score 4); and 4+ (highest density, Score 5). The number of swabs with each score was tabulated from swabs collected at Month 10. Density at missed visits prior to loss to follow-up/final visit was imputed from the subsequent visit.

Outcome measures

Outcome measures
Measure	GBS III-TT Vaccine n=287 Participants The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).	Td Vaccine n=284 Participants The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
The Density of Type III GBS Cultured From Vaginal Swabs at Month 10 Negative	273 Swabs	279 Swabs
The Density of Type III GBS Cultured From Vaginal Swabs at Month 10 Broth only	2 Swabs	1 Swabs
The Density of Type III GBS Cultured From Vaginal Swabs at Month 10 1+	0 Swabs	0 Swabs
The Density of Type III GBS Cultured From Vaginal Swabs at Month 10 2+	3 Swabs	1 Swabs
The Density of Type III GBS Cultured From Vaginal Swabs at Month 10 3+	3 Swabs	0 Swabs
The Density of Type III GBS Cultured From Vaginal Swabs at Month 10 4+	6 Swabs	3 Swabs

SECONDARY outcome

Timeframe: Month 12

Population: All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.

The density of type III GBS is an ordinal response with six Density Levels: negative (lowest density, Score 0); broth only (Score 1); 1+ (Score 2); 2+ (Score 3); 3+ (Score 4); and 4+ (highest density, Score 5). The number of swabs with each score was tabulated from swabs collected at Month 12. Density at missed visits prior to loss to follow-up/final visit was imputed from the subsequent visit.

Outcome measures

Outcome measures
Measure	GBS III-TT Vaccine n=283 Participants The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).	Td Vaccine n=277 Participants The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
The Density of Type III GBS Cultured From Vaginal Swabs at Month 12 Negative	266 Swabs	272 Swabs
The Density of Type III GBS Cultured From Vaginal Swabs at Month 12 Broth only	2 Swabs	0 Swabs
The Density of Type III GBS Cultured From Vaginal Swabs at Month 12 1+	0 Swabs	0 Swabs
The Density of Type III GBS Cultured From Vaginal Swabs at Month 12 2+	3 Swabs	1 Swabs
The Density of Type III GBS Cultured From Vaginal Swabs at Month 12 3+	1 Swabs	2 Swabs
The Density of Type III GBS Cultured From Vaginal Swabs at Month 12 4+	11 Swabs	2 Swabs

SECONDARY outcome

Timeframe: Month 14

Population: All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.

The density of type III GBS is an ordinal response with six Density Levels: negative (lowest density, Score 0); broth only (Score 1); 1+ (Score 2); 2+ (Score 3); 3+ (Score 4); and 4+ (highest density, Score 5). The number of swabs with each score was tabulated from swabs collected at Month 14. Density at missed visits prior to loss to follow-up/final visit was imputed from the subsequent visit.

Outcome measures

Outcome measures
Measure	GBS III-TT Vaccine n=274 Participants The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).	Td Vaccine n=273 Participants The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
The Density of Type III GBS Cultured From Vaginal Swabs at Month 14 Negative	259 Swabs	268 Swabs
The Density of Type III GBS Cultured From Vaginal Swabs at Month 14 Broth only	3 Swabs	0 Swabs
The Density of Type III GBS Cultured From Vaginal Swabs at Month 14 1+	2 Swabs	1 Swabs
The Density of Type III GBS Cultured From Vaginal Swabs at Month 14 2+	1 Swabs	0 Swabs
The Density of Type III GBS Cultured From Vaginal Swabs at Month 14 3+	4 Swabs	2 Swabs
The Density of Type III GBS Cultured From Vaginal Swabs at Month 14 4+	5 Swabs	2 Swabs

SECONDARY outcome

Timeframe: Month 16

Population: All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.

The density of type III GBS is an ordinal response with six Density Levels: negative (lowest density, Score 0); broth only (Score 1); 1+ (Score 2); 2+ (Score 3); 3+ (Score 4); and 4+ (highest density, Score 5). The number of swabs with each score was tabulated from swabs collected at Month 16. Density at missed visits prior to loss to follow-up/final visit was imputed from the subsequent visit.

Outcome measures

Outcome measures
Measure	GBS III-TT Vaccine n=269 Participants The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).	Td Vaccine n=267 Participants The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
The Density of Type III GBS Cultured From Vaginal Swabs at Month 16 Negative	257 Swabs	260 Swabs
The Density of Type III GBS Cultured From Vaginal Swabs at Month 16 Broth only	2 Swabs	2 Swabs
The Density of Type III GBS Cultured From Vaginal Swabs at Month 16 1+	1 Swabs	1 Swabs
The Density of Type III GBS Cultured From Vaginal Swabs at Month 16 2+	1 Swabs	0 Swabs
The Density of Type III GBS Cultured From Vaginal Swabs at Month 16 3+	3 Swabs	0 Swabs
The Density of Type III GBS Cultured From Vaginal Swabs at Month 16 4+	5 Swabs	4 Swabs

SECONDARY outcome

Timeframe: Month 18

Population: All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.

The density of type III GBS is an ordinal response with six Density Levels: negative (lowest density, Score 0); broth only (Score 1); 1+ (Score 2); 2+ (Score 3); 3+ (Score 4); and 4+ (highest density, Score 5). The number of swabs with each score was tabulated from swabs collected at Month 18. Density at missed visits prior to loss to follow-up/final visit was imputed from the subsequent visit.

Outcome measures

Outcome measures
Measure	GBS III-TT Vaccine n=263 Participants The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).	Td Vaccine n=263 Participants The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
The Density of Type III GBS Cultured From Vaginal Swabs at Month 18 Negative	255 Swabs	256 Swabs
The Density of Type III GBS Cultured From Vaginal Swabs at Month 18 Broth only	0 Swabs	2 Swabs
The Density of Type III GBS Cultured From Vaginal Swabs at Month 18 1+	1 Swabs	0 Swabs
The Density of Type III GBS Cultured From Vaginal Swabs at Month 18 2+	1 Swabs	1 Swabs
The Density of Type III GBS Cultured From Vaginal Swabs at Month 18 3+	2 Swabs	0 Swabs
The Density of Type III GBS Cultured From Vaginal Swabs at Month 18 4+	4 Swabs	4 Swabs

Adverse Events

GBS III-TT Vaccine

Serious events: 14 serious events

Other events: 304 other events

Deaths: 0 deaths

Td Vaccine

Serious events: 22 serious events

Other events: 320 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Sharon Hillier, Ph.D.

University of Pittsburgh School of Medicine

Phone: 412-641-6435

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Measure	GBS III-TT Vaccine n=326 participants at risk The experimental arm received a single dose of GBS III-TT vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid. The Safety Analysis Cohort is comprised of all vaccinated women, categorized according to the product received, regardless of their randomized assignment.	Td Vaccine n=337 participants at risk The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine). The Safety Analysis Cohort is comprised of all vaccinated women, categorized according to the product received, regardless of their randomized assignment.
Infections and infestations Nasopharyngitis	17.2% 56/326 • Number of events 61 • Solicited reactogenicity was collected for 7 days after vaccination. Unsolicited serious and non-serious adverse events were collected throughout the 18-month duration of subject participation. The Safety Analysis Cohort is comprised of all vaccinated women, categorized according to the product received, regardless of their randomized assignment. Due to vaccination errors, the number of participants in the Td group for the Safety Analysis Cohort (n=337) exceeds the number randomized to this group (n=334).	16.3% 55/337 • Number of events 71 • Solicited reactogenicity was collected for 7 days after vaccination. Unsolicited serious and non-serious adverse events were collected throughout the 18-month duration of subject participation. The Safety Analysis Cohort is comprised of all vaccinated women, categorized according to the product received, regardless of their randomized assignment. Due to vaccination errors, the number of participants in the Td group for the Safety Analysis Cohort (n=337) exceeds the number randomized to this group (n=334).
Infections and infestations Vaginitis bacterial	13.5% 44/326 • Number of events 51 • Solicited reactogenicity was collected for 7 days after vaccination. Unsolicited serious and non-serious adverse events were collected throughout the 18-month duration of subject participation. The Safety Analysis Cohort is comprised of all vaccinated women, categorized according to the product received, regardless of their randomized assignment. Due to vaccination errors, the number of participants in the Td group for the Safety Analysis Cohort (n=337) exceeds the number randomized to this group (n=334).	18.1% 61/337 • Number of events 90 • Solicited reactogenicity was collected for 7 days after vaccination. Unsolicited serious and non-serious adverse events were collected throughout the 18-month duration of subject participation. The Safety Analysis Cohort is comprised of all vaccinated women, categorized according to the product received, regardless of their randomized assignment. Due to vaccination errors, the number of participants in the Td group for the Safety Analysis Cohort (n=337) exceeds the number randomized to this group (n=334).
Infections and infestations Fungal infection	13.5% 44/326 • Number of events 52 • Solicited reactogenicity was collected for 7 days after vaccination. Unsolicited serious and non-serious adverse events were collected throughout the 18-month duration of subject participation. The Safety Analysis Cohort is comprised of all vaccinated women, categorized according to the product received, regardless of their randomized assignment. Due to vaccination errors, the number of participants in the Td group for the Safety Analysis Cohort (n=337) exceeds the number randomized to this group (n=334).	13.4% 45/337 • Number of events 68 • Solicited reactogenicity was collected for 7 days after vaccination. Unsolicited serious and non-serious adverse events were collected throughout the 18-month duration of subject participation. The Safety Analysis Cohort is comprised of all vaccinated women, categorized according to the product received, regardless of their randomized assignment. Due to vaccination errors, the number of participants in the Td group for the Safety Analysis Cohort (n=337) exceeds the number randomized to this group (n=334).
Nervous system disorders Headache	39.9% 130/326 • Number of events 130 • Solicited reactogenicity was collected for 7 days after vaccination. Unsolicited serious and non-serious adverse events were collected throughout the 18-month duration of subject participation. The Safety Analysis Cohort is comprised of all vaccinated women, categorized according to the product received, regardless of their randomized assignment. Due to vaccination errors, the number of participants in the Td group for the Safety Analysis Cohort (n=337) exceeds the number randomized to this group (n=334).	35.3% 119/337 • Number of events 119 • Solicited reactogenicity was collected for 7 days after vaccination. Unsolicited serious and non-serious adverse events were collected throughout the 18-month duration of subject participation. The Safety Analysis Cohort is comprised of all vaccinated women, categorized according to the product received, regardless of their randomized assignment. Due to vaccination errors, the number of participants in the Td group for the Safety Analysis Cohort (n=337) exceeds the number randomized to this group (n=334).
Infections and infestations Urinary tract infection	10.7% 35/326 • Number of events 46 • Solicited reactogenicity was collected for 7 days after vaccination. Unsolicited serious and non-serious adverse events were collected throughout the 18-month duration of subject participation. The Safety Analysis Cohort is comprised of all vaccinated women, categorized according to the product received, regardless of their randomized assignment. Due to vaccination errors, the number of participants in the Td group for the Safety Analysis Cohort (n=337) exceeds the number randomized to this group (n=334).	8.6% 29/337 • Number of events 34 • Solicited reactogenicity was collected for 7 days after vaccination. Unsolicited serious and non-serious adverse events were collected throughout the 18-month duration of subject participation. The Safety Analysis Cohort is comprised of all vaccinated women, categorized according to the product received, regardless of their randomized assignment. Due to vaccination errors, the number of participants in the Td group for the Safety Analysis Cohort (n=337) exceeds the number randomized to this group (n=334).
Infections and infestations Sinusitis	7.1% 23/326 • Number of events 33 • Solicited reactogenicity was collected for 7 days after vaccination. Unsolicited serious and non-serious adverse events were collected throughout the 18-month duration of subject participation. The Safety Analysis Cohort is comprised of all vaccinated women, categorized according to the product received, regardless of their randomized assignment. Due to vaccination errors, the number of participants in the Td group for the Safety Analysis Cohort (n=337) exceeds the number randomized to this group (n=334).	8.9% 30/337 • Number of events 38 • Solicited reactogenicity was collected for 7 days after vaccination. Unsolicited serious and non-serious adverse events were collected throughout the 18-month duration of subject participation. The Safety Analysis Cohort is comprised of all vaccinated women, categorized according to the product received, regardless of their randomized assignment. Due to vaccination errors, the number of participants in the Td group for the Safety Analysis Cohort (n=337) exceeds the number randomized to this group (n=334).
Infections and infestations Vulvovaginal mycotic infection	5.5% 18/326 • Number of events 19 • Solicited reactogenicity was collected for 7 days after vaccination. Unsolicited serious and non-serious adverse events were collected throughout the 18-month duration of subject participation. The Safety Analysis Cohort is comprised of all vaccinated women, categorized according to the product received, regardless of their randomized assignment. Due to vaccination errors, the number of participants in the Td group for the Safety Analysis Cohort (n=337) exceeds the number randomized to this group (n=334).	5.6% 19/337 • Number of events 26 • Solicited reactogenicity was collected for 7 days after vaccination. Unsolicited serious and non-serious adverse events were collected throughout the 18-month duration of subject participation. The Safety Analysis Cohort is comprised of all vaccinated women, categorized according to the product received, regardless of their randomized assignment. Due to vaccination errors, the number of participants in the Td group for the Safety Analysis Cohort (n=337) exceeds the number randomized to this group (n=334).
Infections and infestations Influenza	4.3% 14/326 • Number of events 15 • Solicited reactogenicity was collected for 7 days after vaccination. Unsolicited serious and non-serious adverse events were collected throughout the 18-month duration of subject participation. The Safety Analysis Cohort is comprised of all vaccinated women, categorized according to the product received, regardless of their randomized assignment. Due to vaccination errors, the number of participants in the Td group for the Safety Analysis Cohort (n=337) exceeds the number randomized to this group (n=334).	5.6% 19/337 • Number of events 21 • Solicited reactogenicity was collected for 7 days after vaccination. Unsolicited serious and non-serious adverse events were collected throughout the 18-month duration of subject participation. The Safety Analysis Cohort is comprised of all vaccinated women, categorized according to the product received, regardless of their randomized assignment. Due to vaccination errors, the number of participants in the Td group for the Safety Analysis Cohort (n=337) exceeds the number randomized to this group (n=334).
General disorders Tenderness	71.8% 234/326 • Number of events 234 • Solicited reactogenicity was collected for 7 days after vaccination. Unsolicited serious and non-serious adverse events were collected throughout the 18-month duration of subject participation. The Safety Analysis Cohort is comprised of all vaccinated women, categorized according to the product received, regardless of their randomized assignment. Due to vaccination errors, the number of participants in the Td group for the Safety Analysis Cohort (n=337) exceeds the number randomized to this group (n=334).	81.9% 276/337 • Number of events 276 • Solicited reactogenicity was collected for 7 days after vaccination. Unsolicited serious and non-serious adverse events were collected throughout the 18-month duration of subject participation. The Safety Analysis Cohort is comprised of all vaccinated women, categorized according to the product received, regardless of their randomized assignment. Due to vaccination errors, the number of participants in the Td group for the Safety Analysis Cohort (n=337) exceeds the number randomized to this group (n=334).
General disorders Pain (at Injection Site)	53.7% 175/326 • Number of events 175 • Solicited reactogenicity was collected for 7 days after vaccination. Unsolicited serious and non-serious adverse events were collected throughout the 18-month duration of subject participation. The Safety Analysis Cohort is comprised of all vaccinated women, categorized according to the product received, regardless of their randomized assignment. Due to vaccination errors, the number of participants in the Td group for the Safety Analysis Cohort (n=337) exceeds the number randomized to this group (n=334).	66.2% 223/337 • Number of events 223 • Solicited reactogenicity was collected for 7 days after vaccination. Unsolicited serious and non-serious adverse events were collected throughout the 18-month duration of subject participation. The Safety Analysis Cohort is comprised of all vaccinated women, categorized according to the product received, regardless of their randomized assignment. Due to vaccination errors, the number of participants in the Td group for the Safety Analysis Cohort (n=337) exceeds the number randomized to this group (n=334).
General disorders Malaise	31.6% 103/326 • Number of events 103 • Solicited reactogenicity was collected for 7 days after vaccination. Unsolicited serious and non-serious adverse events were collected throughout the 18-month duration of subject participation. The Safety Analysis Cohort is comprised of all vaccinated women, categorized according to the product received, regardless of their randomized assignment. Due to vaccination errors, the number of participants in the Td group for the Safety Analysis Cohort (n=337) exceeds the number randomized to this group (n=334).	32.9% 111/337 • Number of events 111 • Solicited reactogenicity was collected for 7 days after vaccination. Unsolicited serious and non-serious adverse events were collected throughout the 18-month duration of subject participation. The Safety Analysis Cohort is comprised of all vaccinated women, categorized according to the product received, regardless of their randomized assignment. Due to vaccination errors, the number of participants in the Td group for the Safety Analysis Cohort (n=337) exceeds the number randomized to this group (n=334).
Musculoskeletal and connective tissue disorders Myalgia	27.9% 91/326 • Number of events 91 • Solicited reactogenicity was collected for 7 days after vaccination. Unsolicited serious and non-serious adverse events were collected throughout the 18-month duration of subject participation. The Safety Analysis Cohort is comprised of all vaccinated women, categorized according to the product received, regardless of their randomized assignment. Due to vaccination errors, the number of participants in the Td group for the Safety Analysis Cohort (n=337) exceeds the number randomized to this group (n=334).	33.2% 112/337 • Number of events 112 • Solicited reactogenicity was collected for 7 days after vaccination. Unsolicited serious and non-serious adverse events were collected throughout the 18-month duration of subject participation. The Safety Analysis Cohort is comprised of all vaccinated women, categorized according to the product received, regardless of their randomized assignment. Due to vaccination errors, the number of participants in the Td group for the Safety Analysis Cohort (n=337) exceeds the number randomized to this group (n=334).
Gastrointestinal disorders Nausea	16.6% 54/326 • Number of events 54 • Solicited reactogenicity was collected for 7 days after vaccination. Unsolicited serious and non-serious adverse events were collected throughout the 18-month duration of subject participation. The Safety Analysis Cohort is comprised of all vaccinated women, categorized according to the product received, regardless of their randomized assignment. Due to vaccination errors, the number of participants in the Td group for the Safety Analysis Cohort (n=337) exceeds the number randomized to this group (n=334).	18.1% 61/337 • Number of events 61 • Solicited reactogenicity was collected for 7 days after vaccination. Unsolicited serious and non-serious adverse events were collected throughout the 18-month duration of subject participation. The Safety Analysis Cohort is comprised of all vaccinated women, categorized according to the product received, regardless of their randomized assignment. Due to vaccination errors, the number of participants in the Td group for the Safety Analysis Cohort (n=337) exceeds the number randomized to this group (n=334).
General disorders Injection site swelling	9.8% 32/326 • Number of events 32 • Solicited reactogenicity was collected for 7 days after vaccination. Unsolicited serious and non-serious adverse events were collected throughout the 18-month duration of subject participation. The Safety Analysis Cohort is comprised of all vaccinated women, categorized according to the product received, regardless of their randomized assignment. Due to vaccination errors, the number of participants in the Td group for the Safety Analysis Cohort (n=337) exceeds the number randomized to this group (n=334).	16.0% 54/337 • Number of events 54 • Solicited reactogenicity was collected for 7 days after vaccination. Unsolicited serious and non-serious adverse events were collected throughout the 18-month duration of subject participation. The Safety Analysis Cohort is comprised of all vaccinated women, categorized according to the product received, regardless of their randomized assignment. Due to vaccination errors, the number of participants in the Td group for the Safety Analysis Cohort (n=337) exceeds the number randomized to this group (n=334).
General disorders Injection site erythema	12.0% 39/326 • Number of events 39 • Solicited reactogenicity was collected for 7 days after vaccination. Unsolicited serious and non-serious adverse events were collected throughout the 18-month duration of subject participation. The Safety Analysis Cohort is comprised of all vaccinated women, categorized according to the product received, regardless of their randomized assignment. Due to vaccination errors, the number of participants in the Td group for the Safety Analysis Cohort (n=337) exceeds the number randomized to this group (n=334).	13.4% 45/337 • Number of events 45 • Solicited reactogenicity was collected for 7 days after vaccination. Unsolicited serious and non-serious adverse events were collected throughout the 18-month duration of subject participation. The Safety Analysis Cohort is comprised of all vaccinated women, categorized according to the product received, regardless of their randomized assignment. Due to vaccination errors, the number of participants in the Td group for the Safety Analysis Cohort (n=337) exceeds the number randomized to this group (n=334).
General disorders Pyrexia	10.1% 33/326 • Number of events 33 • Solicited reactogenicity was collected for 7 days after vaccination. Unsolicited serious and non-serious adverse events were collected throughout the 18-month duration of subject participation. The Safety Analysis Cohort is comprised of all vaccinated women, categorized according to the product received, regardless of their randomized assignment. Due to vaccination errors, the number of participants in the Td group for the Safety Analysis Cohort (n=337) exceeds the number randomized to this group (n=334).	9.5% 32/337 • Number of events 32 • Solicited reactogenicity was collected for 7 days after vaccination. Unsolicited serious and non-serious adverse events were collected throughout the 18-month duration of subject participation. The Safety Analysis Cohort is comprised of all vaccinated women, categorized according to the product received, regardless of their randomized assignment. Due to vaccination errors, the number of participants in the Td group for the Safety Analysis Cohort (n=337) exceeds the number randomized to this group (n=334).
General disorders Chills	9.2% 30/326 • Number of events 30 • Solicited reactogenicity was collected for 7 days after vaccination. Unsolicited serious and non-serious adverse events were collected throughout the 18-month duration of subject participation. The Safety Analysis Cohort is comprised of all vaccinated women, categorized according to the product received, regardless of their randomized assignment. Due to vaccination errors, the number of participants in the Td group for the Safety Analysis Cohort (n=337) exceeds the number randomized to this group (n=334).	9.8% 33/337 • Number of events 33 • Solicited reactogenicity was collected for 7 days after vaccination. Unsolicited serious and non-serious adverse events were collected throughout the 18-month duration of subject participation. The Safety Analysis Cohort is comprised of all vaccinated women, categorized according to the product received, regardless of their randomized assignment. Due to vaccination errors, the number of participants in the Td group for the Safety Analysis Cohort (n=337) exceeds the number randomized to this group (n=334).